FDA Inspection 739613 — Modern Products, Inc.
The FDA completed an inspection of Modern Products, Inc. on September 6, 2011 in Mequon, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 6, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Mequon, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1007 | 21 CFR 110.10(b)(9) | Precautions against contamination--micro, foreign substances |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |
| 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 |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |