FDA Inspection 611251 — Aetna Felt Corporation
The FDA completed an inspection of Aetna Felt Corporation on Sep 11, 2009 in Allentown, 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 11, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Allentown, PA (United States)
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 |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |