For example, describe changes to equipment, procedures, and practices that will ensure meaningful ongoing data is collected to promptly detect and respond to emerging risks in your classified areas. 201 B/1 written production, control, or distribution records specifically associated with a batch of a drug product for at least one year after the expiration date of the batch. To learn more, please visit www.dcat.org. Your response is inadequate. o implementation of oversight and approval of investigations, as well as discharging of all other QU duties to ensure identity, strength, quality, and purity of all products. Why opt for RGI motor insurance this monsoon? ICICI Prudential Large & Mid Cap Fund Direct Pla.. Sun Pharma gets warning letter from US FDA for its Halol site. Sun Pharma subsidiary resolves USFDA warning letter An independent retrospective review of all complaints, including the associated investigations, for discoloration and particulates, for sterile drug products within expiry as of the date of this letter. Sun Pharma AAP to burn copies of Delhi ordinance on July 3, Jaishankar blames China for downturn in bilateral ties, 'You have no power to dismiss my minister': Stalin tells guv, Why caste may be the new religion for 2024, Bolsonaro's political hopes die, barred from office till 2030, Last day to link Aadhaar with PAN card: Things to keep in mind, French cops won right to shoot at drivers, but got 'no training', Terms of Use and Grievance Redressal Policy. A comprehensive, independent assessment of your change management system. For reprint rights: Times Syndication Service, Sun Pharma gets FDA import warning for India plant, shares drop, Government hikes interest rates on select small saving schemes for second quarter, Bank Holidays July 2023 Full List: Banks in India to remain closed for 15 days in July, Sensex tops 64,000, Nifty 1 9,000 on strong eco, FII buying, Higher pension deadline moved 15 days to July 11. A thorough retrospective review and risk assessment that evaluates how poor aseptic technique and cleanroom behavior may have affected the quality and sterility of your drug products. You should immediately and comprehensively assess your companys global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements. Your email address will not be published. manufacturing value chain. You also failed to extend the scope of your investigation to potentially impacted batches of medroxyprogesterone acetate injectable suspension USP manufactured in this room since the last preventive maintenance of the (b)(4), approximately two months before the leak was observed. Post the September 2014 inspection, the US FDA has withheld future product approvals from the Halol facility. The site is FDA Warning Letter & Inspection Observation Trends You failed to perform a timely risk assessment to evaluate if the quality and sterility of your distributed drug products were affected by these deficiencies. Water then collected over the (b)(4) partition ceiling prior to entering the aseptic filling room where medroxyprogesterone acetate injectable suspension USP, was manufactured. Sun House, Plot No. FDA slaps Sun Pharma with warning letter on Indian plant Warning Letter to Sun Pharmaceuticals Takes FDA Requests to PLAN, Yearly Before sharing sensitive information, make sure you're on a federal government site. The response does not identify any impurity standards used in your procedures and does not provide the procedures that your firm was using to conduct the trial and unofficial runs. We posted the FDA letter due to the serious and ongoing nature of Your investigation report noted water accumulated on the service floor due to a leak from an old, punctured (b)(4). frequently performs unofficial testing of samples, disregards the results, and reports results from additional tests. A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The warning letter also said that the pharma giant had failed to establish an adequate system to monitor environmental conditions. During our inspection, our investigators observed specific violations including, but not limited to, the following. Your response also did not include a risk assessment that thoroughly evaluates the design and lifecycle control of manufacturing equipment including (b)(4) and (b)(4). This will alert our moderators to take actions, Published On Dec 17, 2022 at 06:33 AM IST, Sun Pharma gets warning letter from USFDA for Halol plant. Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. The US Food and Drug Administration (FDA) has slammed Sun Pharma, the countrys largest generic drug maker, for manufacturing violations such as failure to The essential resource for The failure to proactively identify deficiencies and implement timely and sustainable corrective actions and preventive actions (CAPA) is unacceptable because it puts patients at risk. Indian generics company Sun Pharmaceutical Industries took another hit from the FDA, receiving an FDA warning letter after the company failed to adequately address development association for companies engaged in the global bio/pharmaceutical manufacturing value chain. o All human interactions within the ISO 5 area Vigilant and responsive environmental and personnel monitoring programs should be designed to provide meaningful information on the state of control of your aseptic processing environment, it said. Your smoke studies demonstrated non-unidirectional, recirculating airflow on and around the funnel. The company expects to respond to the warning letter with a detailed plan within the stipulated time frame. o Personnel Flows and Material Flows (throughout all rooms used to conduct and support sterile operations) (Warning Letter) 12/23/2015. Also read |FDA's warning letter points to cGMP violations at Halol facility: Sun Pharma. Your media fills failed to accurately simulate commercial operations. Sun Pharma gets warning letter from US FDA for its Halol site Warning Letter to Sun Pharma Halol, India (facility unrelated to Ranbaxy) (December 15, 2022) Warning Letter to Sun Pharma Halol, India (facility unrelated to Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). During the inspection your analytical testing identified that the pellets contained (b)(4) API. The assessment should also include, but not be limited to, evaluating: 4. The Warning Letter issued by USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. live, learn and work. Unlock your 30 days free access to ETPrime now. It has provided periodic updates to the US FDA on its commitments. First Australians and Traditional Custodians of the lands where we The identically named GC data files that were deleted had been created at different times and contained disparate data. 381(a)(3). Warning Letter to Sun Pharmaceuticals Takes FDA Requests Your response is inadequate in that you did not conduct an adequate investigation into the pervasive practice of deleting files, said FDA in its letter. We use cookies and other tracking technologies to improve your browsing experience on our site, show personalize content and targeted ads, analyze site traffic, and understand where our audience is coming from. January 13, 2023 Indian generics company Sun Pharmaceutical Industries took another hit from the FDA, receiving an FDA warning letter after the company failed to 1. development association for companies engaged in the global bio/pharmaceutical manufacturing value chain. This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. The government has allowed Chinese gearmaker ZTE to provide optical transmission equipment worth over 200 crore to Vodafone Idea (Vi) for a network upgradation project. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. The US Supreme Court on Thursday struck down race-conscious student admissions programmes at Harvard University and the University of North Carolina in a sharp setback to affirmative action policies often used to increase the number of Black, Hispanic and other underrepresented minority groups on campuses. Our inspection found the aseptic operations simulated during your media fills were not sufficiently representative of commercial aseptic manufacturing operations for medroxyprogesterone acetate injectable suspension USP, 150 mg/mL, 1 ml prefilled syringes and vials. Drug giant Sun Pharma warned over manufacturing Operators bodies and hands were in immediate proximity to the sterile API during dispensing, compounding, and syringe-loading in the filling station. In a warning letter, the FDA has highlighted a series of lapses at Sun Pharmas Gujarat plant, which has been put on an import alert list by the US drug regulator. Web(FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 Maharashtra Your Reason has been Reported to the admin. Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 10,000, FDA's warning letter points to cGMP violations at Halol facility: Sun Pharma, Sun Pharma clarifies on US FDA import alert on Halol plant, Ashneer Grover's 10-point note on statesmen investors amid Byju's crisis, Divya Gokulnath shares employees' texts after Byju's townhall: 'We didn't come this far', Ram Charan and Upasana Konidela reveal name of new born daughter, Harsh Goenka's tribute to HDFC's Deepak Parekh on retirement mentions Sachin Tendulkar. Save your favourite articles with seamless reading experience, Get updates on your preferred social platform. 2019-11993 TAPMI Request for form 483 issued to Sun Pharma at the end of cGMP inspection at its Halol, Your response is inadequate. Sun Pharmaceutical Industries Ltd. Correct any violations promptly. Include their responsibilities and an estimated time frame for completion of their activities. The letter is titled consent The .gov means its official.Federal government websites often end in .gov or .mil. assign and identify raw materials with a distinctive code, batch, or receipt number, and to identify the disposition of materials. (FDA) inspected your pharmaceutical manufacturing facility, Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol, Gujarat. ZTE Receives Govt Security Clearance to Supply Gear to Vi, TCS Fires 6 Hands, Bans as Many Staffing Firms, Is Air India retiring its Maharaja? During the inspection, the investigators found approximately 10 waste bags containing torn or partially destroyed raw data CGMP records related to a variety of manufacturing activities. Your protocol to test any drug product, within expiry and manufactured on non-dedicated (b)(4) equipment, for contamination. WebLearn about the types of warning letters on FDA's website. Sun Pharmaceutical Industries Inc 8/25/10 - FDAnews Identify your response with FEI 3002809586 and ATTN: Ganesh Joshi, Compliance Officer. The dispensing and compounding steps were high-risk steps, and there were no additional sterilization steps following these operations. o whether procedures used by your firm are robust and appropriate See FDAs guidance document Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing, at https://www.fda.gov/media/71026/download. We identified significant violations of current good manufacturing practice (CGMP) 356C(b). blanks, standards, samples, and system suitability runs). For reprint rights: Continue reading with one of these options: Login to get access to some exclusive stories, Get access to exclusive stories, expert opinions &, Valid only with UPI, Credit & Debit Cards Autopay, Inciting hatred against a certain community, 15 FDA The US Food and Drug Administration (FDA) has slammed Sun Pharma, the countrys largest generic drug maker, for manufacturing violations such as failure to investigate discrepancies in batches of products, not cleaning equipment used in drug manufacturing and failing to prevent contamination at its Halol facility in Gujarat. MUMBAI: Indias largest drug maker Sun Pharma has received a warning letter from the US FDA for its manufacturing facility based in Halol, Gujarat. We acknowledge that after our inspection you voluntarily recalled five marketed testosterone cypionate injection lots associated with the (b)(4) investigations. A comprehensive review of your media fill program, and CAPA to ensure an accurate simulation, including appropriately incorporating the worst-case conditions of commercial manufacturing. All Right Reserved. The US Food and Drug Administration (FDA) has issued a Warning Letter to Sun Pharmaceutical Industries Ltd. as a result of a September 2014 inspection, for the companys facility located at Halol, Gujarat in India. o Air quality in the ISO 5 area and surrounding room In your response, you state the leak was isolated to the day it was observed. Enforcement Activities | FDA, Recalls, Market Withdrawals and Safety Alerts, Warning Letters and Notice of Violation Letters to Pharmaceutical Companies, Guidance, Compliance, & Regulatory Information. Provide an updated timeline for implementation of your program, including a summary of the CAPA steps you will be undertaking to ensure effective remediation. Your CAPA plan to implement routine, vigilant operations management oversight (corporate and local) of facilities and equipment. For example, data from the inspection indicated: A. In your response you acknowledge the inadequacies of your environmental and personnel monitoring program. Copyright 2023 Bennett, Coleman & Co. Ltd. All rights reserved. The ISO 5 area is critical because sterile drug products are exposed and therefore vulnerable to contamination. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated drug products may have been released for distribution. Tom Clancys Jack Ryan: Streaming now on Prime Video, US to ease visas for skilled Indian workers as PM Modi visits, Sensex hits record high of 63,588.31 in early trade, Bank giant bigger than Morgan Stanley arises from HDFC Bank, HDFC Ltd merger, PM Modi speaks to Putin, discusses Ukraine & armed mutiny. You waited over five months to initiate a recall of the affected batches. WebForm 483 of Sun Pharma's inspection by US FDA at Halol in Gujarat. The US FDAs warning letter said that Sun Pharma had failed to use suitable equipment in manufacturing drug products. Find & Invest in bonds issued by top corporates, PSU Banks, NBFCs, and much more. Pouches used in commercial manufacturing may also have been previously opened and re-sealed. WebMumbai, Sept 19, 2011: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that the U.S. Food and Drug PLAN. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated, the warning letter said. See FDAs guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk-management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, at https://www.fda.gov/media/71023/download. Inadequately cleaned and maintained equipment can lead to cross contamination and poor quality drug products. These results cause the drug product to be adulterated within the meaning of 501(b) of the Act, [21 U.S.C. 2-Year FDA Warning Letters-2015 Furthermore, internal communications and systems were not implemented by management to ensure all levels of the company can effectively identify major quality risks so they are promptly escalated to senior management, whenever needed. Also describe the frequency of quality unit (QU) oversight (e.g., audit) during aseptic processing and its support operations. The FDA is asking India-based Sun Pharmaceuticals to conduct tests and turn over reams of paperwork in response to a warning letter alleging more than a dozen cGMP It further stated: Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, Include steps to ensure routine and effective supervisory oversight for all production batches. Your change management program should include provisions for determining change effectiveness. WebThe FDA has issued a warning letter to Sun Pharmaceutical for its plant in Halol, India, a facility that accounts for about 15% of its U.S. sales. If a media fill program fails to incorporate contamination risk factors and closely simulate actual drug product exposure, the state of process control and sterility assurance cannot be accurately assessed. Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. However, the FDA was not convinced and placed the Halol facility on import alert on December 7. While we acknowledge you initiated actions to address this specific leak, your investigation failed to sufficiently address facility damage and the potential for microbial (i.e., particularly fungal) contamination that could persist in the facility due to water leaks and moisture. The role of senior management leadership is critical to ensure successful functioning of a robust and effective quality system. Get DCAT Value Chain Insights delivered to your inbox every Friday! The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Indian generics company Sun Pharmaceutical Industries took another hit from the FDA, receiving an FDA warning letter after the company failed to adequately address the agencys concerns over lapses in aseptic procedures, inadequate media fills, poorly designed and ventilated cleanrooms, and flaws in vial-filling machinery. December 15, 2022 FDA Letter to Sun Pharma Made public by FDA on January 10, 2023. Although you sealed gaps in the ceiling, you did not sufficiently inspect the service floor, (b)(4) LAF ceiling, and HVAC duct floor for mold growth and water damage after the repairs were made. FDA Follows Import Alert With Warning Letter to Sun Citing