FDA Inspection 1052934 — Years to Your Health, Inc.
The FDA completed an inspection of Years to Your Health, Inc. on May 25, 2018 in Irving, 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
- May 25, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15618 | 21 CFR 111.180(b)(1) | Written procedures - components |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 1565 | 21 CFR 110.35(d)(3) | Non-food-contact surfaces (S) |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |
| 986 | 21 CFR 110.10(b)(2) | Personal cleanliness |