# FDA 483 - Acharya Chemicals - March 15, 2024

Source: https://www.globalkeysolutions.net/records/483/acharya-chemicals/880b9b79-3656-4b37-9d4c-ee7e0000447f

> FDA 483 for Acharya Chemicals on March 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acharya Chemicals
- Inspection Date: 2024-03-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Acharya Chemicals, a manufacturer in Thane, India, was cited for significant deficiencies in its quality control processes. The inspection revealed a failure to adequately investigate out-of-specification (OOS) results and implement appropriate corrective and preventive actions. This indicates a critical lapse in ensuring product quality and process control.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)

Company: https://www.globalkeysolutions.net/companies/acharya-chemicals/b04fbbb1-7564-477d-af9e-baf86fd3720d

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