FDA Inspection 1026709 — Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc.
The FDA completed an inspection of Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc. on September 26, 2017 in Lynnwood, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 26, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lynnwood, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15883 | 21 CFR 111.75(i) | Corrective action plan |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16043 | 21 CFR 111.503 | Written procedures - returned dietary supplement; destroyed |