FDA Inspection
Pekana Naturheilmittel GmbHPekana Naturheilmittel GmbH – FDA Inspection, Mar 8, 2013
Record Details
This FDA Inspection record concerns Pekana Naturheilmittel GmbH, with an inspection on March 8, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pekana Naturheilmittel GmbH
- Inspection Date
- March 8, 2013
- Product Type
- Drugs
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ID · d4739d94-c78d-4b40-9e46-ff8cd3b5b997
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 826409
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
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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 |
| June 1, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 6, 2016 | 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 1054535 - 2018-06-01
- FDA Inspection 981424 - 2016-05-06
- FDA Inspection 542411 - 2008-10-02
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