1045246
Product Packaging West, Inc. — FEI 3004429449
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 13, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- N Hollywood, CA (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 |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |