FDA Inspection 798636 — Mueller Sports Medicine, Inc
The FDA completed an inspection of Mueller Sports Medicine, Inc on Sep 6, 2012 in Prairie Du Sac, WI. 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: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 6, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Prairie Du Sac, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15785 | 21 CFR 111.410(b) | Label, packaging - discrepancies |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |