FDA Inspection 937383 — Perfect Water and Essentials LLC,
The FDA completed an inspection of Perfect Water and Essentials LLC, on August 6, 2015 in Salt Lake City, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 6, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15552 | 21 CFR 111.260(j)(2) | Batch record - initials; each step |
| 15558 | 21 CFR 111.260(k)(1) | Batch record - identifier; packaging |
| 15623 | 21 CFR 111.180(b)(2) | Records - receiving; components, packaging, labels, products |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15709 | 21 CFR 111.325(b)(2) | Laboratory methodology followed |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15741 | 21 CFR 111.210(h)(3)(i) | Components, verify weight, measure |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |