FDA Inspection 735705 — Universal Supplement, Inc.
The FDA completed an inspection of Universal Supplement, Inc. on July 21, 2011 in Vista, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 25 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 21, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15388 | 21 CFR 111.10(b) | Personnel - hygienic practices |
| 15395 | 21 CFR 111.10(b)(5) | Gloves |
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15449 | 21 CFR 111.15(f)(2) | Plumbing - sewage, liquid waste |
| 15450 | 21 CFR 111.15(f)(3) | Plumbing - source of contamination |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15478 | 21 CFR 111.20(f) | Physical plant - bulbs, fixtures, skylights |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15510 | 21 CFR 111.27(a)(7) | Compressed air, gases |
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |