# FDA 483 - EMS Acquisition Corp - July 22, 2022

Source: https://www.globalkeysolutions.net/records/483/ems-acquisition-corp/9b2a06bd-a8dd-4572-956c-3be0cda5e510

> FDA 483 for EMS Acquisition Corp on July 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EMS Acquisition Corp
- Inspection Date: 2022-07-22
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: EMS Contract Packaging, a pharmaceutical manufacturer in Hatfield, PA, was inspected by the FDA from July 18-22, 2022. The inspection revealed a repeat observation from 2015 concerning the absence of written procedures for production and process controls. Specifically, the firm failed to validate or verify manufacturing and filling processes for its OTC drug products, indicating a significant deficiency in ensuring product quality and purity.

## Related Documents

- [483 - 2025-10-24](https://www.globalkeysolutions.net/records/483/ems-acquisition-corp/2e2701e2-6ee4-43d6-b330-efd781b9c5e3)

## Related Officers

- [Elaine E. Gilfillan](https://www.globalkeysolutions.net/people/elaine-e-gilfillan/def582d9-9cb9-49d2-841c-76005ba68210)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)

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

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