FDA 483 - Zydus Lifesciences Limited - March 10, 2022

On March 10, 2022, the FDA issued a Form 483 to Cadila Healthcare Limited, a sterile drug manufacturer located in Jarod, Gujarat, India, following an inspection from February 24 to March 10, 2022. The report was issued to Mr. Laxmikant Tiwari, Site Head, Chief - Manufacturing.

The inspection revealed three observations related to the firm's quality system and facility maintenance:

1. **Stability Testing Program Not Followed:** The written stability testing program was not adhered to, specifically regarding the timely completion of testing. The Quality Unit failed to test approximately 250 stability samples within the predefined (b)(4) days as required by SOP 0317-SOP-QC-00132. Examples include delayed testing for (b)(4) INJECTION USP (b) mg/ml and (b)(4) INJECTION USP (b) mg/ml batches, both delayed by 275 days at the 122-day timepoint.

2. **Annual Product Quality Review Procedures Not Followed:** Written procedures for Annual Product Quality Reviews (APQR) were not followed. SOP 0317-SOP-QA-00076 requires APQRs to be approved within (b)(4) days of the scheduled time period. The Quality Unit failed to complete APQRs