FDA Inspection
Brookfield Medical/Surgical Supplies, Inc.Brookfield Medical/Surgical Supplies, Inc. – FDA Inspection, May 10, 2024
Record Details
This FDA Inspection record concerns Brookfield Medical/Surgical Supplies, Inc., with an inspection on May 10, 2024, issued by the New England District Office, covering human drugs.
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ID · c7268e48-69de-4f05-9f4d-64589280b064
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1238439
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.67(b)Written procedures not established/followed
- FDCA 503B(a)(10)(B)Drug product container, fails to include
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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 |
| 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 |
| April 9, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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