FDA Inspection 987698 — Laboratorium Soluna Heilmittel Gmbh
The FDA completed an inspection of Laboratorium Soluna Heilmittel Gmbh on Sep 2, 2016 in Donauworth. 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). 11 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 2, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Donauworth (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3605 | 21 CFR 211.160(b)(1) | Specification description of sample/testing |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |