FDA 483 - Alkem Laboratories Ltd - March 27, 2018

This FDA Form 483 document details numerous deficiencies observed during an inspection.

**Facility and Operations:** The inspection revealed issues across manufacturing, quality control, and laboratory areas.

**Violations and Observations:**

* **Quality Control Unit Deficiencies (Repeat Observation):** * Absence of a functional quality control unit. * Failure to initiate recalls for out-of-specification (OOS) products distributed to the U.S. (e.g., (b)(4) Tablets USP (b)(4) mg, Batch #(b)(4)). * Failure to track, trend, and investigate 259 system suitability failures since January 1, 2018, with a logbook for invalid data being destroyed. * Lack of responsibility and authority for the quality control unit to approve/reject components, in-process materials, and drug products. * **Untimely Sample Analysis (Repeat Observation):** * Significant backlog of pending stability, in-process, and finished product samples (e.g., late stability batches since January 2017, finished products since September 2017). * Delayed stability testing for distributed commercial batches (e.g., Tablets, 1mg Batch manufactured November 2016, pending 2-month stability testing). * Confirmed OOS results for related substances (e.g