FDA Inspection 724735 — PRECISION FORMULATIONS
The FDA completed an inspection of PRECISION FORMULATIONS on May 19, 2011 in Coppell, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 19, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Coppell, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15589 | 21 CFR 111.160(c) | Packaging, labels - quarantine |
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15802 | 21 CFR 111.560(c) | Product complaint - review, investigation |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 9939 | 21 CFR 120.7(c) | All hazards not considered |