FDA Inspection 1035240 — Universal Packaging Systems, Inc.
The FDA completed an inspection of Universal Packaging Systems, Inc. on Nov 30, 2017 in Batavia, OH. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 30, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Batavia, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1956 | 21 CFR 211.180(e)(1) | Representative Number of Batches for Annual Review |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4576 | 21 CFR 211.192 | No written record of investigation |