FDA Warning Letter for Indian API manufacturer

The FDA inspection of Shree Jaya Laboratories PVT. LTD. from 4 to 12 September 2024 uncovered serious GMP violations, including:

1. Inadequate Cleaning & Maintenance: Equipment labeled as “cleaned” still contained product residues. The production area was poorly maintained, with a damaged ceiling. The manufacturer did not assess cross-contamination risks.
2. Inadequate Handling of Quality Defects: The company’s investigation into a customer complaint about particles was insufficient. Equipment in poor condition, with corrosion and rust, was not adequately addressed in the investigation.
3. Batch Documentation & Data Integrity Issues: Original batch records were found discarded, and second versions were provided upon request. Records were not completed in real-time but by a production manager overseeing multiple areas, raising concerns about documentation accuracy.

The FDA demanded a review of documentation practices and corrective actions to ensure real-time, accurate recordkeeping by the responsible employees. More details are available on the FDA website.

12-05-2025