784078
Acuity Specialty Products, Inc. — FEI 3006317477
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 5, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chambersburg, 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 |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2019 | 21 CFR 211.188(b)(7) | Documentation of Actual Yield and Theoretical Yield |
| 2200 | 21 CFR 211.186(b)(4) | Variation in the Amount of Components Used |
| 2203 | 21 CFR 211.186(b)(7) | Theoretical Yield and Percentages |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4313 | 21 CFR 211.84(c)(6) | Containers Marked to Show Samples Taken |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |