FDA Inspection
Brookfield Medical/Surgical Supplies, Inc.Brookfield Medical/Surgical Supplies, Inc. – FDA Inspection, Apr 9, 2015
Record Details
This FDA Inspection record concerns Brookfield Medical/Surgical Supplies, Inc., with an inspection on April 9, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 9, 2015
- Product Type
- Drugs
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ID · fc7a768d-2c4f-4132-a633-e107cd1f0755
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 924250
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.111Establishment of time limitations
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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 18, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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