FDA Inspection 635597 — All Oxygen Refills, Inc.
The FDA completed an inspection of All Oxygen Refills, Inc. on December 18, 2009 in Opa Locka, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 18 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Opa Locka, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 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 |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4341 | 21 CFR 211.142(a) | Quarantine - written procedures |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |