# FDA 483 - Alchem International Private Limited - July 15, 2024

Source: https://www.globalkeysolutions.net/records/483/alchem-international-private-limited/6e3fa318-39ce-46ea-8500-2c2d44d7fbcb

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

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## Details

- Record Type: 483
- Company Name: Alchem International Private Limited
- Inspection Date: 2024-07-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Alchem International Limited, an API manufacturer in Neemrana, India, received a Form 483 with two observations. The inspection revealed failures in establishing procedures for verifying USP test methods and in investigating critical deviations. These issues led to the release of potentially impacted product batches without proper assessment, indicating significant deficiencies in quality control and deviation management.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.globalkeysolutions.net/companies/alchem-international-private-limited/2cc04b82-2743-4f38-965a-f9bed4b4f429

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