FDA Inspection
Ulmer Pharmacal CoUlmer Pharmacal Co – FDA Inspection, May 17, 2012
Record Details
This FDA Inspection record concerns Ulmer Pharmacal Co, with an inspection on May 17, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ulmer Pharmacal Co
- Inspection Date
- May 17, 2012
- Product Type
- Drugs
View Company Profile
ID · 0e7ea3ec-fedd-48d6-b2c0-a6cb7cd80b83
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 782613
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
Full citation text and observation details available on the Dashboard.
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 |
| July 11, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 791562 - 2012-07-11
- FDA Inspection 608267 - 2009-08-19
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