FDA Inspection 889394 — Fidelio Healthcare Limburg GmbH
The FDA completed an inspection of Fidelio Healthcare Limburg GmbH on May 23, 2014 in Limburg. 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). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 23, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Limburg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |