# FDA 483 - API Solutions Inc. - April 10, 2019

Source: https://www.globalkeysolutions.net/records/483/api-solutions-inc/2571d7a6-87bc-408c-8853-d8379923eb25

> FDA 483 for API Solutions Inc. on April 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: API Solutions Inc.
- Inspection Date: 2019-04-10
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: APT Solutions Inc., a relabeler in Daphne, AL, received two observations during an FDA inspection. The firm failed to ensure that each lot of components was withheld from use until sampled, tested, examined, and released by the quality control unit. Additionally, there was no written testing program in place to assess the stability characteristics of drug products.

## Related Officers

- [Owner/Inspector](https://www.globalkeysolutions.net/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)

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

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7