FDA Inspection
Brookfield Medical/Surgical Supplies, Inc.Brookfield Medical/Surgical Supplies, Inc. – FDA Inspection, Apr 18, 2017
Record Details
This FDA Inspection record concerns Brookfield Medical/Surgical Supplies, Inc., with an inspection on April 18, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e6c9c49b-933a-4397-87e4-c4fc07bbb0da
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1009608
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| December 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 28, 2017 | Not classified | New England District Office | |
| April 9, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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