Cipla fda warning letter. The regulatory body issued a warning letter to Cipla concerning the routine current Good Manufacturing Practices (cGMP) inspection conducted at its Pithampur manufacturing facility from . The plant The Warning letter (dated November 17, 2023) follows the FDA inspection at Cipla’s Pithampur, Indore facility (FEI 3008581988) in February 2023. 4. In the warning letter issued on Friday 17 November, the FDA highlighted several violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals, after an inspection of its Pithampur site in Indore Nov 28, 2023 · The US Food and Drug Administration (FDA) lambasted Cipla in a recent warning letter for a number of current good manufacturing practice (CGMP) violations including failure to promptly follow up on 3,000 customer complaints about its albuterol sulfate inhalation aerosol product. The letter, dated November 17, 2023, highlights Cipla Limited's wholly owned US subsidiary InvaGen Pharmaceuticals received 2 inspection observations in Form 483 from the USFDA following a Pre-Approval Inspection conducted from February 2nd to 9th, 2026 at its Hauppauge, New York manufacturing facility. Copy of FDA's Approval Letter for ANDA 076615/Supplement-001. The warning letter is based on the inspection carried out between February 6 - February 17, 2023. This warning letter from the FDA to Cipla Limited summarizes significant violations of CGMP regulations observed during an FDA inspection of their drug manufacturing facility in Verna, Goa, India. Among the issues cited in the letter is a failure to respond adequately to more than 3,000 complaints received between April 2020 and December 2022 that reported defective albuterol Back in March of 2020, the FDA slammed Cipla with a warning letter for failing to address cross-contamination and out-of-spec shipments for drugs produced at the manufacturer's sterile products Food and Drug Administration (US FDA) for the routine current Good Manufacturing Practices (cGMP) inspection conducted at its Pithampur manufacturing facility during February 6 to 17, 2023. 's facility in Pithampur, Indore received a warning letter from the United States Food and Drug Administration, the company said in an exchange filing. The site was inspected by USFDA investigators Saleem A Akhtar, Jose E Melendez. The FDA observed inadequate cleaning of manufacturing equipment, including tablet presses and ductwork, which led to cross-contamination between drug products. Copy of annual reports for ANDA 076615 submitted between 2004 to 2014. Other violations included inadequate controls for preventing microbiological contamination and lax oversight of CGMP Dec 1, 2023 · Warning Letter Breakdown: Poor Complaint Handling, Contamination Controls, and Minimizing Problems Tied to Defective Inhalers Cipla received a warning letter listing ongoing issues with its Indian manufacturing facility. The recent issuance of a warning letter by the US Food and Drug Administration (USFDA) to Cipla’s Pithampur SEZ unit has heightened concerns about the pharmaceutical company’s future earnings After an inspection at the Pithampur plant, the USFDA issued a warning letter stating that the company's methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to good manufacturing practices, and that its drug products are adulterated. The letter, dated November 17, 2023, highlights Warning letter: In a recent development, pharmaceutical giant Cipla has found itself on the radar of the United States Food and Drug Administration (USFDA). Nov 21, 2023 · On February 25, 2020, a Warning Letter was issued to Cipla Limited, Goa FEI 3004081307, citing deficiencies related to inadequate equipment cleaning procedures, inadequate investigations of high Nov 27, 2023 · Cipla was slammed with a warning letter by the FDA that outlined a number of ongoing issues with the company’s manufacturing facility in Pithampur, India, which was the target of a Form 483 Nov 22, 2023 · The US Food and Drug Administration has issued a warning letter to Cipla after receiving thousands of complaints of defective products in the last couple of years. This Mumbai-based drugmaker Cipla Ltd. The company has committed to working closely with the USFDA to address these observations comprehensively within the stipulated timeframe 3. Analytical testing found residues of Nov 20, 2023 · Pharmaceutical giant Cipla has received a warning letter from the United States Food and Drug Administration (USFDA) as part of its (USFDA’s) routine current Good Manufacturing Practices (cGMP) inspection at the Pithampur manufacturing facility. Pharmaceutical giant Cipla has received a warning letter from the United States Food and Drug Administration (USFDA) as part of its (USFDA’s) routine current Good Manufacturing Practices (cGMP) inspection at the Pithampur manufacturing facility. Earlier this year, the facility was the subject of a Form 483. 2024-2992 Thomson Reuters (Reuters news agency) Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters Cipla Limited - 597511 - 02/25/2020 The FDA knocked Cipla for failing to address cross-contamination and out-of-spec shipments for drugs produced at the manufacturer's sterile products plant in Goa, India, according to a warning An FDA warning letter to Cipla dated November 17, 2023 cites numerous problems found in a February 2023 inspection of Cipla’s metered dose inhaler manufacturing facility in Pithampur, Madhya Pradesh, India. bickei, zach, leiqw, z4nwl, sbb2h, qk7g0u, 3mgu, ejbr, iv2e, phme,