# FDA 483 - Apharma, Inc - September 29, 2010

Source: https://www.keypedia.com/records/483/apharma-inc/e012f5ec-d437-4149-ab02-a0ebe42237c3

> FDA 483 for Apharma, Inc on September 29, 2010. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apharma, Inc
- Inspection Date: 2010-09-29
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Apharma, Inc. in Salisbury, MD, a non-clinical laboratory, was inspected by the FDA from September 20-29, 2010. The inspection revealed significant deficiencies in record retention, adherence to study protocols, study director oversight, quality assurance unit responsibilities, and equipment calibration and maintenance. These issues indicate a lack of control over critical aspects of non-clinical laboratory studies.

## Related Officers

- [Tamika E. Allen](https://www.keypedia.com/people/tamika-e-allen/4be57200-f9f1-472c-a9f8-edf80fababcc)

Company: https://www.keypedia.com/companies/apharma-inc/d5907b59-921f-43aa-86d5-fd56823a2adb

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e