826409
Pekana Naturheilmittel GmbH — FEI 3002037061
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2013
- Fiscal Year
- 2013
- 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 |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |
| 4576 | 21 CFR 211.192 | No written record of investigation |