FDA Inspection 975303 — Pure Energy Products, Inc.
The FDA completed an inspection of Pure Energy Products, Inc. on June 24, 2016 in Oklahoma City, OK. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 24, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Oklahoma City, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15821 | 21 CFR 111.60(a) | Production, in- process control system - design, quality |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |