FDA Inspection 1238439 — Brookfield Medical/Surgical Supplies, Inc.
The FDA completed an inspection of Brookfield Medical/Surgical Supplies, Inc. on May 10, 2024 in Brookfield, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brookfield, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 22789 | FDCA 503B(a)(10)(B) | Drug product container, fails to include |