FDA Inspection 837927 — ADH Health Products Inc
The FDA completed an inspection of ADH Health Products Inc on June 13, 2013 in Congers, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 13, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Congers, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15462 | 21 CFR 111.20(d)(1)(iv) | Physical plant - temperature, humidity controls |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15886 | 21 CFR 111.77(b) | Specifications not met - identity; component, reject |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |