# FDA 483 - Allchem Lifescience Private Limited - May 17, 2024

Source: https://www.keypedia.com/records/483/allchem-lifescience-private-limited/f368b8bc-f1dc-4103-935d-b23dd20bb102

> FDA 483 for Allchem Lifescience Private Limited on May 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allchem Lifescience Private Limited
- Inspection Date: 2024-05-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Allchem Lifescience Private Limited, a nonsterile intermediate manufacturer in Vadodara, Gujarat, India, revealed significant deficiencies in quality control. Observations included a lack of a written stability testing program for intermediates, inadequate microbial testing procedures for water and finished products, and failure to follow written sanitation procedures regarding pest control.

## Related Officers

- [Ankur C. Patel](https://www.keypedia.com/people/ankur-c-patel/602c7d14-2c48-4929-a07b-6e4c235d7f13)

Company: https://www.keypedia.com/companies/allchem-lifescience-private-limited/d93ac4fb-dd82-4232-8d6a-a4b285d5af29

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