# FDA 483 - AvKARE - November 02, 2022

Source: https://www.keypedia.com/records/483/avkare/2abf18db-2a34-40ca-9b84-ab044b3b46c6

> FDA 483 for AvKARE on November 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AvKARE
- Inspection Date: 2022-11-02
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: AVKARE LLC in Pulaski, TN, was inspected from October 31 to November 2, 2022. The inspection revealed a significant quality control deficiency, specifically the absence of written procedures for label investigations and the review of batch records. This indicates a lack of adequate controls over critical quality processes, raising concerns about product quality and regulatory compliance.

## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)

Company: https://www.keypedia.com/companies/avkare/7412af8d-e223-4f5b-90f3-24a1cc0b3838

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea