FDA Inspection
Mayne Pharma International PTY LTDFDA Inspection 1257835 - Mayne Pharma International PTY LTD - March 21, 2025
Record Details
This FDA Inspection record concerns Mayne Pharma International PTY LTD, with an inspection on March 21, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · fb195325-06ba-4ffd-90e0-c4c64fbcbfc5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1257835
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Mayne Pharma International PTY LTD
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 2, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 15, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mayne Pharma International PTY LTD
- FDA Inspection 1110711 - 2019-10-18
- FDA Inspection 1035729 - 2017-09-15
- FDA Inspection 945811 - 2015-09-25
- FDA Inspection 846520 - 2013-08-02
- FDA Inspection 588986 - 2009-05-15
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