FDA Inspection 1121832 — Great HealthWorks, Inc.
The FDA completed an inspection of Great HealthWorks, Inc. on March 23, 2020 in Fort Lauderdale, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 23, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fort Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 16007 | 21 CFR 111.135 | Quality control operations - product complaints |