FDA Inspection 937182 — Future Pak LLC
The FDA completed an inspection of Future Pak LLC on Aug 5, 2015 in Wixom, MI. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 5, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wixom, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |