# FDA 483 - API Solutions Inc. - May 27, 2026

Source: https://www.keypedia.com/records/483/api-solutions-inc/d6aa98ea-7e88-4912-822f-3208f69357df

> FDA 483 for API Solutions Inc. on May 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: API Solutions Inc.
- Inspection Date: 2026-05-27
- Product Type: drugs
- Office Name: FDA District Office — Philadelphia, Pennsylvania
- Summary: An FDA inspection of API Solutions Inc., a re-labeler in Daphne, AL, revealed significant deficiencies in quality control and production processes. Observations included a failure to conduct temperature mapping studies and maintain records for drug product storage areas, a Quality Unit oversight in detecting missing signatures on batch records, and inadequate GMP training for employees. These issues indicate a lack of adherence to established procedures and CGMP requirements.

## Related Documents

- [483 - 2019-04-10](https://www.keypedia.com/records/483/api-solutions-inc/2571d7a6-87bc-408c-8853-d8379923eb25)

## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/api-solutions-inc/3a56c727-1ecb-4996-8688-41e8c70d62e1

Office: https://www.keypedia.com/offices/fda-district-office-philadelphia-pennsylvania/e70a6e70-40b2-49e4-8360-c3db36c4d2a0