FDA Inspection 824681 — Oxygen Development, L.L.C.
The FDA completed an inspection of Oxygen Development, L.L.C. on March 29, 2013 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). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 29, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Palm Springs, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 1794 | 21 CFR 211.80(d) | Disposition recorded by lot identification |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |