FDA Inspection
Temmler Pharma GmbH & Co. KGTemmler Pharma GmbH & Co. KG – FDA Inspection, Dec 4, 2015
Record Details
This FDA Inspection record concerns Temmler Pharma GmbH & Co. KG, with an inspection on December 4, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Temmler Pharma GmbH & Co. KG
- Inspection Date
- December 4, 2015
- Product Type
- Drugs
View Company Profile
ID · 29076f6d-cc67-4075-8cca-45ef31cf7b3b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953823
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.176Failing to test for penicillin cross-contamination
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Other FDA inspections of Temmler Pharma GmbH & Co. KG
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 16, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 5, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 22, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 27, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Temmler Pharma GmbH & Co. KG
- FDA Inspection 1255610 - 2022-07-13
- FDA Inspection 1178993 - 2020-09-16
- FDA Inspection 884796 - 2014-06-05
- FDA Inspection 788609 - 2012-06-22
- FDA Inspection 668329 - 2010-05-27
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