FDA 483 - Suven Pharmaceuticals Limited - February 15, 2018

This FDA Form 483 document outlines several deficiencies observed during an inspection.

**Facility and Operations:** The firm operates HPLCs and UPLCs using Empower 3 or EZ CHROM ELITE for raw material and finished product analysis. They also manufacture Intermediates and APIs in a Production Block Area and produce drug products like Tablets and Capsules.

**Violations and Observations:**

1. **Computer System Controls (21 CFR 211.68(b)):** The firm lacked documentation of electronic review of audit trails for HPLCs and UPLCs. Electronic data review for analyses in the QC Formulations Laboratory was not conducted prior to August 2017. 2. **Equipment Cleaning and Maintenance (21 CFR 211.67(a)):** Several pieces of equipment (e.g., -3109, -3139, -3137) in the Production Block Area, identified as "cleaned," showed signs of discoloration, residue (including white powdery and black residue), damaged Teflon tape, and a hole, indicating inadequate cleaning and visual inspection. 3. **Manufacturing Batch Records (21 CFR 211.188(b)):** In-process checks for Tablets, Batch were not documented in the batch record, though verified by QA. Recorded weights were not verified by a second person. 4. **Raw Material Sampling Procedures (2