FDA Inspection 642682 — Milbar Laboratories, Inc.
The FDA completed an inspection of Milbar Laboratories, Inc. on January 27, 2010 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 27, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |