# FDA 483 - Apitoria Pharma Private Limited - October 25, 2019

Source: https://www.keypedia.com/records/483/apitoria-pharma-private-limited/c0a8f710-466e-418e-9774-c7f4bef69156

> FDA 483 for Apitoria Pharma Private Limited on October 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2019-10-25
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Aurobindo Pharma Limited Unit VIII in Jinnaram Mandal, Telangana, was cited with four observations during an FDA inspection. The inspection revealed deficiencies in equipment cleaning validation, thoroughness of deviation investigations, Quality Unit procedures for stability testing of reprocessed batches, and completeness of batch production records. These issues indicate a lack of adequate controls and documentation in critical manufacturing processes.

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## Related Officers

- [Kenneth H. Williams](https://www.keypedia.com/people/kenneth-h-williams/20a225cd-a3d5-478f-ae04-2a8e119df8a6)
- [PreApproval Manager](https://www.keypedia.com/people/gayle-s-lawson/cd8061de-f089-408c-bbfc-c7c7a5635dd7)

Company: https://www.keypedia.com/companies/apitoria-pharma-private-limited/3fa64839-667a-4ce5-930b-a1935f0c2b38

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd