# FDA 483 - Wockhardt USA LLC - June 06, 2024

Source: https://www.globalkeysolutions.net/records/483/wockhardt-usa-llc/646e029d-7dc3-46c4-8ff5-d58aad18c420

> FDA 483 for Wockhardt USA LLC on June 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wockhardt USA LLC
- Inspection Date: 2024-06-06
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Wockhardt USA LLC identified significant deficiencies in post-marketing surveillance and reporting. The firm lacked written procedures for monitoring adverse drug experiences and failed to submit numerous required periodic adverse drug experience reports and annual reports for its ANDA products. These issues indicate a systemic problem with regulatory compliance regarding drug safety and reporting obligations.

## Related Officers

- [Mayar M. Mussa](https://www.globalkeysolutions.net/people/mayar-m-mussa/4f39b1c8-93a6-4bc9-a800-5f802db48be6)

Company: https://www.globalkeysolutions.net/companies/wockhardt-usa-llc/014f1eef-1611-4235-9b43-ed9633b04f33

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248