# FDA 483 - Watson Pharma Private Limited - May 20, 2025

Source: https://www.keypedia.com/records/483/watson-pharma-private-limited/3e8153e8-e63f-40fc-8595-889b98f0edb4

> FDA 483 for Watson Pharma Private Limited on May 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Watson Pharma Private Limited
- Inspection Date: 2025-05-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Watson Pharma Private Limited, a drug product manufacturer in Verna, India, was inspected by the FDA from May 12-20, 2025. The inspection revealed significant deficiencies in cross-contamination controls for shared manufacturing equipment, inadequate investigations into unexplained discrepancies and out-of-specification results, and a lack of established control procedures for manufacturing processes, particularly regarding visual inspection and defect recording. These issues indicate a failure to ensure drug product quality and consistency.

## Related Officers

- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.keypedia.com/companies/watson-pharma-private-limited/846d9c2f-be10-415a-b681-5436e078ebfd

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8