FDA Inspection 705221 — Years To Your Health, Inc.
The FDA completed an inspection of Years To Your Health, Inc. on Dec 15, 2010 in Irving, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 15, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15382 | 21 CFR 111.8 | Written procedures - personnel qualifications |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15623 | 21 CFR 111.180(b)(2) | Records - receiving; components, packaging, labels, products |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15783 | 21 CFR 111.410(d) | Manufacturing history |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |