FDA Inspection 702543 — PRECISION FORMULATIONS
The FDA completed an inspection of PRECISION FORMULATIONS on December 10, 2010 in Coppell, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 19 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 10, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Coppell, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12743 | 21 CFR 120.8(b)(4) | HACCP plan - monitoring procedures not adequate |
| 12747 | 21 CFR 120.8(b)(3) | HACCP plan - critical limits not listed or not adequate |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15835 | 21 CFR 111.70(c)(2) | Documentation specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 9919 | 21 CFR 120.10(a) | Corrective action - predetermined plan inadequate |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9939 | 21 CFR 120.7(c) | All hazards not considered |
| 9946 | 21 CFR 120.11(b) | Validation - reviewer's qualifications |
| 9955 | 21 CFR 120.11(a)(1) | Verification activities - minimum |