FDA Inspection
Cyclomedica Australia Pty LtdCyclomedica Australia Pty Ltd – FDA Inspection, Aug 8, 2023
Record Details
This FDA Inspection record concerns Cyclomedica Australia Pty Ltd, with an inspection on August 8, 2023, issued by the Office of Inspections and Investigations.
- Inspection Date
- August 8, 2023
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ID · f96053ac-821d-48d4-9b52-06c76572d46c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1214903
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Cyclomedica Australia Pty Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2024 | Not classified | Office of Inspections and Investigations | |
| February 8, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for Cyclomedica Australia Pty Ltd
- FDA Inspection 1253733 - 2024-09-25
- FDA Inspection 1123505 - 2019-02-08
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