FDA Inspection 736116 — Eurofins SF Analytical Laboratories, Inc.
The FDA completed an inspection of Eurofins SF Analytical Laboratories, Inc. on Jul 27, 2011 in Horsham, PA. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 27, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Horsham, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |