FDA Inspection 1167870 — Positive Promotions
The FDA completed an inspection of Positive Promotions on April 25, 2022 in Hauppauge, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 25, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |