FDA Inspection 941080 — Acuity Specialty Products, Inc.
The FDA completed an inspection of Acuity Specialty Products, Inc. on September 11, 2015 in Chambersburg, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 20 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 11, 2015
- Fiscal Year
- 2015
- 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 |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 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 |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 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 |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3633 | 21 CFR 211.170(b)(1) | Reserve sample retention time |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |