FDA Inspection 604827 — Modern Products, Inc.
The FDA completed an inspection of Modern Products, Inc. on August 21, 2009 in Mequon, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 21, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Mequon, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 4371 | 21 CFR 211.188(b)(9) | Description of containers and closures |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 8938 | FDCA 760(c)(1) | Timing of AE report submission (non-RX drugs) |