FDA Inspection 953161 — Universal Packaging Systems, Inc.
The FDA completed an inspection of Universal Packaging Systems, Inc. on Dec 22, 2015 in Chino, CA. 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
- Dec 22, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chino, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4576 | 21 CFR 211.192 | No written record of investigation |