FDA Inspection 1054535 — Pekana Naturheilmittel GmbH
The FDA completed an inspection of Pekana Naturheilmittel GmbH on Jun 1, 2018 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 1, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kislegg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |