FDA Inspection
Brookfield Medical/Surgical Supplies, Inc.Brookfield Medical/Surgical Supplies, Inc. – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Brookfield Medical/Surgical Supplies, Inc., with an inspection on December 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a760b43e-5525-4266-a31e-399840c31aca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075504
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Brookfield Medical/Surgical Supplies, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2026 | Not classified | New England District Office | Drug Quality Assurance |
| May 10, 2024 | VAI | New England District Office | Drug Quality Assurance |
| June 28, 2017 | Not classified | New England District Office | |
| April 18, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 9, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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