FDA Inspection
Brooks Steriscience LimitedBrooks Steriscience Limited – FDA Inspection, Nov 12, 2024
Record Details
This FDA Inspection record concerns Brooks Steriscience Limited, with an inspection on November 12, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 6f2f59fa-f52d-4f37-8913-f1249e1d55fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1254638
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Brooks Steriscience Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2023 | VAI | Office of Inspections and Investigations |
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