FDA Inspection 823829 — Milbar Laboratories, Inc.
The FDA completed an inspection of Milbar Laboratories, Inc. on April 2, 2013 in East Haven, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 2, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |