760764
Bentley Laboratories LLC — FEI 2244819
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 30, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |
| 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 |