FDA Inspection 642941 — BREATHE EASY THERAPEUTICS Inc
The FDA completed an inspection of BREATHE EASY THERAPEUTICS Inc on Jan 25, 2010 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 25, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 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 |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |