Strides Pharma Science Limited – FDA 483, May 26, 2017

This FDA Form 483 details observations from an inspection, highlighting several deficiencies in the firm's quality system and manufacturing processes for capsule products.

**Key Observations:**

1. **Inadequate Complaint Investigations:** Written records of investigations into unexplained discrepancies, particularly multiple complaints regarding capsules sticking to bottles, lacked conclusive root cause determination and appropriate follow-up. Investigations did not extend to evaluate if quality measures taken during a specific step represented the entire batch.

2. **Non-Representative Sampling Plan:** Samples of in-process materials for conformance testing were not representative. There was no scientific rationale or data to support the sampling plan for capsule testing. Manufacturing batch records were inadequate, only specifying "take samples from" and directing operators to collect only a total of [redacted] capsules per [redacted] for testing, despite each [redacted] containing approximately [redacted] capsules. This applies to US marketed capsules [redacted].

3. **Lack of Written Production and Process Control Procedures:** The firm lacked written procedures for production and process controls designed to assure drug product identity, strength, quality, and purity. Specifically, hold times were either not established, or where established, the batch sizes for hold time studies did not represent commercial batches and were not justified.