1160527
Colorlab Cosmetics, Inc. — FEI 3005000375
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 6, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Williston, VT (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1371 | 21 CFR 211.101(a) | Batches Formulated to less than 100% |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3555 | 21 CFR 211.48(b) | Drains--Size, Back-siphonage Prevention |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4322 | 21 CFR 211.101(d) | Component release checked by 2nd person |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |