FDA Inspection 883153 — Guest Packaging LLC
The FDA completed an inspection of Guest Packaging LLC on Jun 6, 2014 in Rahway, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 6, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rahway, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |