FDA Inspection 1250182 — OurPharma LLC
The FDA completed an inspection of OurPharma LLC on September 27, 2024 in Fayetteville, AR. 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
- September 27, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fayetteville, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 22779 | FDCA 503B(b)(2)(A) | All inclusive product report, not submitted |
| 22787 | FDCA 503B(a)(10)(A) | Drug product labels, fails to include |
| 22789 | FDCA 503B(a)(10)(B) | Drug product container, fails to include |