FDA WARNING_LETTER - Cipla Limited - February 17, 2023

The FDA issued a Warning Letter to Cipla Limited, Mumbai, India, following an inspection from February 6-17, 2023, at their Indore manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated. Additionally, the firm failed to submit a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) Field Alert Report (FAR) within three working days, as required by 21 CFR 314.81(b)(1)(ii).

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** Cipla failed to thoroughly investigate approximately 3,000 complaints (April 2020-December 2022) for Albuterol Sulfate Inhalation Aerosol, primarily "no spray" or "empty/less weight." Investigations were prolonged, lacked timely CAPAs, and did not extend to all potentially affected batches. Despite identifying defective metered dose inhaler (MDI) valves causing drug delivery blockage, the firm classified the issue as "Non-Critical," did not submit a FAR, and took no market action, leaving impacted batches on the market. Subsequent complaints (January-August 2023) with similar issues further indicated unresolved problems. 2.