FDA Inspection 613765 — Fragrance Manufacturing, Inc.
The FDA completed an inspection of Fragrance Manufacturing, Inc. on Sep 21, 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). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 21, 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 |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15556 | 21 CFR 111.260(j)(2)(iv) | Batch record - initials; verifying component |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 16014 | 21 CFR 111.140(b)(1) | QC ops; written procedures; material review, disposition |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |