# FDA 483 - Alkem Laboratories Limited - Unknown Date

Source: https://www.keypedia.com/records/483/alkem-laboratories-limited/3c40742f-ec74-483c-879f-1807cab25107

> FDA 483 for Alkem Laboratories Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alkem Laboratories Limited
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Alkem Laboratories Limited, an API manufacturer in Bharuch district, India, revealed significant quality control deficiencies. The firm failed to establish validated methods for API testing and conducted inadequate investigations into unexpected results, including the status of raw materials after a fire and stability chamber excursions. Additionally, employees lacked required training to perform their assigned functions, indicating a need for improved personnel qualification and documentation practices.

## Related Officers

- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/alkem-laboratories-limited/d83070c7-f17b-450c-a967-a3c21903ba6f

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3