# FDA 483 - Unichem Laboratories Limited - July 15, 2024

Source: https://www.keypedia.com/records/483/unichem-laboratories-limited/d571b3ef-d700-43d4-9574-7b6f524ae5bb

> FDA 483 for Unichem Laboratories Limited on July 15, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Unichem Laboratories Limited
- Inspection Date: 2024-07-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Unichem Laboratories Limited in Pilerne Bardez, Goa, India, revealed significant deficiencies across multiple areas of drug manufacturing. Observations included a lack of an on-site Quality Unit, inadequate oversight of analytical equipment and out-of-specification results, and failures to follow production procedures. The firm also conducted inadequate investigations into microbial contamination and failed to maintain original electronic batch manufacturing records, indicating serious quality system breakdowns.

## Related Documents

- [483 - 2019-07-31](https://www.keypedia.com/records/483/unichem-laboratories-limited/3000e25f-9a9c-4699-8db5-1d064d2276fd)

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/unichem-laboratories-limited/2b8c7905-52a2-4b2e-a97e-0a1d5b2d88ea

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1