FDA 483 - Cipla Limited - July 19, 2019

The FDA Form 483 details significant deficiencies in a facility manufacturing Active Pharmaceutical Ingredients (APIs) and intermediates.

**Facility and Operations:** The inspection revealed issues across quality control, equipment qualification, inventory management, and process/stability validations for API products like (b)(4) USP and (b)(4).

**Violations and Observations:** * **Inadequate OOS Investigations:** Investigations into out-of-specification (OOS) QC analytical results for finished API products are insufficient. Root causes for API drug substance failures are not consistently determined. Analytical data assessment is inadequate, failing to evaluate/eliminate all possible OOS sources. Examples include: * **1021_LAB/INV/10/18/05 & 1021_LAB/INV/10/18/02 ((b)(4) Lots (b)(4) and (b)(4)):** OOS for individual impurity during stability testing, attributed to higher temperature/humidity. However, significant main peak shifts in chromatographic data were not evaluated or compared to USP reference standards. Critical (b)(4) step of (b)(4) for key starting material (b)(4) was not controlled/monitored. * **1021_LAB/OOS/02/19/09 ((b)(4) USP Lot (b)(4)):** OOS for description during