FDA Inspection 819218 — Balassa Laboratories
The FDA completed an inspection of Balassa Laboratories on February 19, 2013 in Port Orange, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 19, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Port Orange, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1845 | 21 CFR 211.84(d)(3) | Container/Closure Written Test Procedure |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4376 | 21 CFR 211.188(b)(4) | Weights and measures of components used |