FDA 483 - Cipla Limited - June 21, 2024

This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in quality control and manufacturing processes.

**Facility and Operations:** The inspection covered a facility manufacturing commercial drug products and active pharmaceutical ingredients (APIs) for the US market, including sterile products from a Unit Line.

**Violations and Observations:**

* **Test Method Validation:** Accuracy, sensitivity, specificity, and reproducibility of test methods for commercial drug products (both approved and distributed, and approved but not yet commercial), APIs, and in-process tests were not established or documented. This violates the firm's SOP 1035-L-0016. * **Environmental Monitoring (EM) Deficiencies:** * Viable surface monitoring in critical Grade A areas of the Unit Line did not ensure microbial contamination recognition. * EM sampling was random, lacking a systematic plan for uniform and representative coverage. Specific examples of infrequent sampling for Lines #13, #1, and #54 were cited. * Swab validation for Grade A viable surface monitoring failed to establish a limit of detection for "no growth" results, despite the Grade A action limit being 0 cfu. A vendor's validation showed no growth after inoculating with 1 cfu and 2 cfu S. aureus, failing to assure 0 cfu for "no growth" results. * Swab validation did not include testing