# FDA 483 - AustarPharma, LLC - April 05, 2023

Source: https://www.keypedia.com/records/483/austarpharma-llc/c9b6df3e-80b0-497d-8628-843e4f7b3468

> FDA 483 for AustarPharma, LLC on April 05, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AustarPharma, LLC
- Inspection Date: 2023-04-05
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Austarpharma LLC, a drug manufacturer in Edison, NJ, was inspected by the FDA from March 22 to April 5, 2023. The inspection revealed significant deficiencies in personnel training for critical laboratory operations and a failure to perform required preventative maintenance on analytical instruments. These issues indicate a lack of adequate quality control and could impact the reliability of product testing.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/daniel-j-min/e8d901f7-c604-48e6-a723-f191dc3cd28c)

Company: https://www.keypedia.com/companies/austarpharma-llc/05a402ea-dcb1-4900-9553-0a3a1b908183

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