FDA Inspection 871069 — Fragrance Manufacturing, Inc.
The FDA completed an inspection of Fragrance Manufacturing, Inc. on Apr 2, 2014 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). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 2, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 15983 | 21 CFR 111.123(a)(7) | Quality control operations - finished batch, specifications |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 16085 | 21 CFR 111.75(c)(3) | Specifications met limits on contamination ; basis |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |