FDA Inspection 787777 — PRECISION FORMULATIONS
The FDA completed an inspection of PRECISION FORMULATIONS on July 10, 2012 in Coppell, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 10, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Coppell, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15580 | 21 CFR 111.155(c)(2) | Quality control - components; tests, examination results |
| 15597 | 21 CFR 111.160(c)(3) | Labels - quality control; approve, release |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |