Download The Economic Times News App to get Daily Market Updates & Live Business News. Enforcement Activities | FDA, Recalls, Market Withdrawals and Safety Alerts, Warning Letters and Notice of Violation Letters to Pharmaceutical Companies, Guidance, Compliance, & Regulatory Information, Regulatory Actions Against Ranbaxy and Sun Pharma, Violation of Consent Decree Letter to Ranbaxy, Consent Decree Correspondence/Non-Compliance Letter to Sun Pharma, FDA Application Integrity Policy Letter to Ranbaxy Laboratories, List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy, Questions & Answers on Drugs Manufactured at Dewas and Paonta Sahib Facilities, Ranbaxy, Warning Letter to Ranbaxy Batamandi (Unit II), Paonta Sahib, India, Warning Letter to Sun Pharma Halol, India, Warning Letter to Ranbaxy Ohm Laboratories, Gloversville, NY, Warning Letter to Ranbaxy Paonta Sahib, India, Warning Letter to Ranbaxy Princeton, NJ. Also describe the frequency of quality unit (QU) oversight (e.g., audit) during aseptic processing and its support operations. Industry Trends on 4000+ Stocks, Get 1 Year Complimentary Subscription of TOI+ worth Rs.799/-, ICICI Prudential India Opportunities Fund-IDCW. 1. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the Francis Godwin This will alert our moderators to take action. FDAfurther citeddata-handling issues inthe companys high-performance liquid chromatography (HPLC) and gas chromatography(GS) analyses. 15 Mumbai 400063 Health with Dr Norman Swan, Take your favourite podcasts and radio with you. Unlock your 30 days free access to ETPrime now. In response to this letter, provide the following: 2. o sufficiency of provisions used for QU oversight throughout your operations to evaluate adherence to appropriate practices The company gave a detailed response to the US regulator on May 31 in response to Form 483. This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. Sun Pharma: Stretched valuation a sticking point, what else to watch out for? Millionaire Dog Selling Miami Villa Once Owned by Madonna, 10 Books About Warren Buffett That You Must Read, Alia Bhatt Net Worth: Know How Rich Is This Brilliant Actress, 11 Ways to Earn Money Online by Selling Digital Products, 10 Habits of Highly Successful Warren Buffett Investors, How to Choose the Right ETF for Your Investment Goals, Ridiculously Expensive Things King Khan Owns, Aamir Khan Net Worth: Know How Rich is Mr. Perfectionist, A SIP calculator is a simple tool that allows individuals to get an idea of the returns on their. A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. Required fields are marked *. Also, colored particles and pellets were observed inside a crevice where the (b)(4) was attached to (b)(4) 1. In its latest statement to the stock exchanges, Sun Pharma said it expects to request for a re-inspection by the US FDA upon completion of its remediation commitments. Earlier in July, Sun cited a number of issues including the integration process with Ranbaxy and the remediation exercise at Halol to impact its revenues and profits for the year. WebThe US Food and Drug Administration (FDA) has issued warning letters to three repackers of active pharmaceutical ingredients (API), B&B Pharmaceuticals, Inc., Read More Sun Pharmas got clearance For Halol Facility From US Regulator +Includes DocuBay and TimesPrime Membership. Your information is being handled in accordance with the. manufacturing value chain, At the firms API facility, FDA said that the firm failed to, At the companys finished drug product manufacturing operations, FDA cited the firm for failure to, Your email address will not be published. To learn more, please visit www.dcat.org. 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 Your email address will not be published. New Delhi: The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture more than one drug product. Office of Compliance The assessment should also include, but not be limited to, evaluating: Your response states that damaged (b)(4) were isolated and not used in filling testosterone cypionate injection but were inadvertently not removed from the manufacturing batch record. sample preparation as prescribed by the method, preparation and testing of standards, reagents, and standard solutions; records of all calculations performed in connection with the test; the signature of the person who performed each test and the datethe tests were performed as well as the date and signature of a second person showing that the original records hadbeen reviewed for accuracy, completeness, and compliance with prescribed acceptance criteria. 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. Include their responsibilities and an estimated time frame for completion of their activities. You failed to adequately clean and maintain your equipment used for drug product manufacturing. You also do not provide a risk assessment for drug products manufactured and distributed using such equipment. The .gov means its official.Federal government websites often end in .gov or .mil. Sun Pharma Receives FDA Warning Letter for Data-Integrity IssuesByEugene. 5. Since the inspection in September 2014, Sun Pharma said it has communicated regularly with the US FDA on the progress of its remediation and on issues of product supply. You also confirm the shiny fragments on the (b)(4) gaskets are (b)(4) and stated that the shedding of metal fragments most likely occurred during the assembly and disassembly process. Dont miss out on ET Prime stories! The Halol facility manufactures injectable products for the US market. Commenting on the development, Dilip Shanghvi, Managing Director, Sun Pharma said, While our team is working hard to ensure that the commitments made to the US FDA in September 2014 are fully completed, we will continue to cooperate with the US FDA and undertake any additional steps necessary to ensure that the US agency is completely satisfied with our remediation of the Halol facility. Center for Drug Evaluation and Research, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations, Sun Pharmaceutical Industries Ltd. - 636199 - 12/15/2022, An operator inserted his gloved hand inside the canister to, An operator touched the product contact surface of the. The essential resource for In its letter, the US FDA pointed out that Sun Pharma failed to thoroughly investigate discrepancies in batches of products at the Halol facility. After you receive this letter, respond to this office in writing within 15 working days. The FDA inspected Sun Pharmas Halol plant from April 26 to May 9, 2022. Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. FDA has issued a Warning Letter to Sun Pharmaceutical Industries for data-integrity issues and related cGMP violations at the companys active pharmaceutical FDA issued the letter in response to an inspection of the pharmaceutical manufacturing facility made on November 13 to November 16, 2013. Provide a detailed action plan to remediate this system. 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. Sun Pharma expects to request a re-inspection by US FDA upon completion of its remediation commitments. Our investigators observed visible residue on (b)(4) 1 after it was identified as clean. 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 'Demand for detail on the Voice is a diversion': Noel Pearson, Cate Blanchett on her new role as a musical genius, What's behind the FDA's warning letter to Sun Pharma? Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality assurance unit oversight, and written procedures. We have various options to advertise with us including Events, Advertorials, Banners, Mailers, etc. Company told to take corrective action immediately. 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. Inappropriately designed vial filling equipment led to substantial extraneous matter contamination in testosterone cypionate injection 200 mg/mL, 1 ml vials. Additionally, your (b)(4) capsules, (b)(4) mg, USP are adulterated under section 501(b) of the FD&C Act, 21 U.S.C. You should include a determination of whether equipment is of appropriate design and a robust program for ongoing control and maintenance. Copyright e-Eighteen.com Ltd. All rights reserved. We reviewed your May 31, 2022, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. However, your firm indicated during the inspection that these damaged (b)(4) could not be reconditioned and acknowledged that they were not suitably designed. Operator movements in the critical areas were not always slow and deliberate. 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. 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. At the end of last year, the US Food and Drug Administration issued a strongly-worded letter to Sun Pharmaceuticals. Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified to assist your firm in meeting CGMP requirements, the FDA said. 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. 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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. o Facility layout 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. We acknowledge Aboriginal and Torres Strait Islander peoples as the You recalled all batches of the drug product following the FDA inspection. Active Pharmaceuticals Ingredients (APIs)/ CGMP. 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. This financial tool allows one to resolve their queries related to Public Provident Fund account. (FDA) inspected your pharmaceutical manufacturing facility, Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol, Gujarat. Likewise, no environmental monitoring was performed where sterile API was manually added to the compounding tank. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, Your CAPA plan to implement routine, vigilant operations management oversight (corporate and local) of facilities and equipment. Finished Pharmaceuticals / Adulterated/ CGMP/. 4. frequently performs unofficial testing of samples, disregards the results, and reports results from additional tests. Sun Pharma Receives FDA Warning LetterByEugene. ( RAPS) The number of warning letters prompted by onsite inspections increased dramatically in FY2022: 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. 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. Examples include, but are not limited to: Your response is inadequate. Your protocol failed to identify these locations as high-risk sampling points for environmental monitoring. 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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