FDA Inspection
Umforana GmbH & Co. KGUmforana GmbH & Co. KG – FDA Inspection, Jun 16, 2015
Record Details
This FDA Inspection record concerns Umforana GmbH & Co. KG, with an inspection on June 16, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Umforana GmbH & Co. KG
- Inspection Date
- June 16, 2015
- Product Type
- Drugs
View Company Profile
ID · fe81d4c5-ec70-48cf-888e-923aa2f660ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935372
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.160(a)Lab controls established, including changes
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Other FDA inspections of Umforana GmbH & Co. KG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Umforana GmbH & Co. KG
- FDA Inspection 1177330 - 2022-04-12
- FDA Inspection 800990 - 2012-09-13
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