FDA Inspection 1005899 — Products By O2, Inc
The FDA completed an inspection of Products By O2, Inc on March 16, 2017 in Fort Lauderdale, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Fort Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |