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. 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 sulfate MDIs.
The main issues addressed in the letter include the failure to investigate quality defect complaints about the MDIs; lack of procedures to ensure sterility of the filling lines; and inadequate quality control systems. According to the warning letter, the agency issued a Form 483 following the inspection and Cipla responded in March 2023; the FDA says that it reviewed the company’s response “in detail” prior to issued the letter.
While acknowledging that the company did issue a recall for 6 batches of the albuterol sulfate inhalers, the letter notes that “the issue with defective valves appears to be unresolved. According to your response, you received numerous additional complaints (about 2,000) between January 2023 and August 2023, with similar issues such as ‘no spray,’ ’empty/less weight,’ and leaky containers.”
The letter warns that, “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. 351(a)(2)(B)” and “strongly” recommends hiring a CGMP consultant.
Read the FDA warning letter.
