FDA Inspection 542411 — Pekana Naturheilmittel GmbH
The FDA completed an inspection of Pekana Naturheilmittel GmbH on Oct 2, 2008 in Kislegg. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 2, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kislegg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |