FDA Inspection 1250745 — Oxygen Development, L.L.C.
The FDA completed an inspection of Oxygen Development, L.L.C. on September 11, 2025 in Palm Springs, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 11, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Palm Springs, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |