# FDA 483 - Pharmaceutical Specialties, Inc. - August 15, 2025

Source: https://www.globalkeysolutions.net/records/483/pharmaceutical-specialties-inc/9b3d4839-3ad0-494f-9de5-4f6436d35e84

> FDA 483 for Pharmaceutical Specialties, Inc. on August 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutical Specialties, Inc.
- Inspection Date: 2025-08-15
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Pharmaceutical Specialties, Inc. in Rochester, MN, was inspected and cited for significant deficiencies in its manufacturing processes for OTC drug products. The inspection revealed failures in microbiological and component testing, inadequate investigations into out-of-specification results and equipment damage, and a deficient stability program. Additionally, the firm lacked proper process re-validation after specification changes and a comprehensive change management program.

## Related Documents

- [483 - 2019-05-03](https://www.globalkeysolutions.net/records/483/pharmaceutical-specialties-inc/4eea6d7a-e4d5-4e11-845f-3031e5075c16)

## Related Officers

- [Beatrix D. Hippe](https://www.globalkeysolutions.net/people/beatrix-d-hippe/4a5a5258-3099-46cd-9e56-2dce60668ac5)
- [Travis V. Hull](https://www.globalkeysolutions.net/people/travis-v-hull/1f3b5843-29ed-4291-8a8a-a2bf3ac36988)

Company: https://www.globalkeysolutions.net/companies/pharmaceutical-specialties-inc/21d8b984-d2b5-4f1e-b1c4-0d27eda2ad40

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d