FDA Inspection 921995 — Advanced Therapies LLC
The FDA completed an inspection of Advanced Therapies LLC on Apr 17, 2015 in Philadelphia, 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 17, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |