# FDA 483 - Joint Stock Company Grindeks - August 24, 2018

Source: https://www.keypedia.com/records/483/joint-stock-company-grindeks/d11d9696-6ca7-4951-af1b-95215a2fc4b6

> FDA 483 for Joint Stock Company Grindeks on August 24, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Joint Stock Company Grindeks
- Inspection Date: 2018-08-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Joint Stock Company Grindeks, an API manufacturer in Riga, Latvia, received a Form 483 citing multiple deficiencies in its operations. Key issues included inadequate controls over electronic laboratory data, incomplete laboratory records, and inappropriate raw material sampling. The firm also failed to properly maintain and clean production equipment, ensure API conformance to specifications, and conduct thorough out-of-specification investigations.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.keypedia.com/companies/joint-stock-company-grindeks/588451a9-559e-4570-a0d8-a7445ad4a2f3

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