FDA Inspection
Pekana Naturheilmittel GmbHPekana Naturheilmittel GmbH – FDA Inspection, Jun 1, 2018
Record Details
This FDA Inspection record concerns Pekana Naturheilmittel GmbH, with an inspection on June 1, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 85ec1d38-c4f6-49b3-a192-49e11a5c9036
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054535
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.122(a)Written procedures describing in detail
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Other FDA inspections of Pekana Naturheilmittel GmbH
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2024 | VAI | Drug Quality Assurance | |
| July 22, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 6, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 2, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pekana Naturheilmittel GmbH
- FDA Inspection 1302516 - 2024-10-10
- FDA Inspection 1156199 - 2021-07-22
- FDA Inspection 981424 - 2016-05-06
- FDA Inspection 826409 - 2013-03-08
- FDA Inspection 542411 - 2008-10-02
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