FDA Inspection 1039029 — The Health Management Group Inc.
The FDA completed an inspection of The Health Management Group Inc. on January 26, 2018 in Akron, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 26, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Akron, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |