# FDA 483 - Pharmaceutical Specialties, Inc. - May 03, 2019

Source: https://www.globalkeysolutions.net/records/483/pharmaceutical-specialties-inc/4eea6d7a-e4d5-4e11-845f-3031e5075c16

> FDA 483 for Pharmaceutical Specialties, Inc. on May 03, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutical Specialties, Inc.
- Inspection Date: 2019-05-03
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Pharmaceutical Specialties, Inc. in Rochester, MN, a manufacturer of OTC drug products, revealed significant deficiencies in their quality control systems. Observations included a lack of written procedures and process validation for drug product manufacturing, as well as inadequate cleaning validation for equipment. Furthermore, the firm's Quality Unit failed to reject a subpotent batch of Vanicream™ Sunscreen, leading to its release and distribution.

## Related Documents

- [483 - 2025-08-15](https://www.globalkeysolutions.net/records/483/pharmaceutical-specialties-inc/9b3d4839-3ad0-494f-9de5-4f6436d35e84)

## Related Officers

- [Scott A. Golladay](https://www.globalkeysolutions.net/people/scott-a-golladay/78c90066-7212-4442-900c-5cdcb677aeec)

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