FDA Inspection
Ulmer Pharmacal CoUlmer Pharmacal Co – FDA Inspection, Jul 11, 2012
Record Details
This FDA Inspection record concerns Ulmer Pharmacal Co, with an inspection on July 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ulmer Pharmacal Co
- Inspection Date
- July 11, 2012
- Product Type
- Devices
View Company Profile
ID · 4764df64-74e1-469c-8cc7-814b3be196dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 791562
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Ulmer Pharmacal Co
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2022 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| August 2, 2017 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| May 17, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 19, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ulmer Pharmacal Co
- FDA Inspection 1177172 - 2022-08-01
- FDA Inspection 1021833 - 2017-08-02
- FDA Inspection 782613 - 2012-05-17
- FDA Inspection 608267 - 2009-08-19
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