# FDA 483 - EMS Acquisition Corp - October 24, 2025

Source: https://www.keypedia.com/records/483/ems-acquisition-corp/2e2701e2-6ee4-43d6-b330-efd781b9c5e3

> FDA 483 for EMS Acquisition Corp on October 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EMS Acquisition Corp
- Inspection Date: 2025-10-24
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: EMS Acquisition Corp, a human drug manufacturer in Hatfield, PA, was cited for significant deficiencies across its quality control and production processes. Observations included inadequate component testing, failure to test for objectionable microorganisms in OTC drug products, poor computer system controls impacting data integrity, and deficient process validation for critical manufacturing steps. These issues indicate a lack of robust controls to assure drug product identity, strength, purity, and quality.

## Related Documents

- [483 - 2022-07-22](https://www.keypedia.com/records/483/ems-acquisition-corp/9b2a06bd-a8dd-4572-956c-3be0cda5e510)

## Related Officers

- [Azeezat M. Lawal](https://www.keypedia.com/people/azeezat-m-lawal/6068345c-a8c8-438e-9b59-f7fc35370a59)

Company: https://www.keypedia.com/companies/ems-acquisition-corp/cee4bc8f-ba39-4d0e-a1b7-afe5724ced65

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8