FDA Inspection
Brooks Steriscience LimitedBrooks Steriscience Limited – FDA Inspection, Feb 1, 2023
Record Details
This FDA Inspection record concerns Brooks Steriscience Limited, with an inspection on February 1, 2023, issued by the Office of Inspections and Investigations.
- Company
- Brooks Steriscience Limited
- Inspection Date
- February 1, 2023
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ID · c1a3d6c2-5e31-4006-ac96-c4b8ea75fbfe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196064
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of Brooks Steriscience Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2024 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
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