Mayne Pharma International Pty Ltd. — FDA Facility Profile
Mayne Pharma International Pty Ltd. is an FDA-registered facility (FEI 3004090027) located in Salisbury South, AU. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Mar 21, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (5 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 3
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 21, 2025 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Absence of Written Procedures (21 CFR 211.100(a)) Scientifically sound laboratory controls (21 CFR 211.160(b)) Storage under appropriate conditions (21 CFR 211.142(b)) |
| Oct 18, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 15, 2017 | No Action Indicated (NAI) | No citations listed |
| Sep 25, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Aug 2, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
| May 15, 2009 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Mayne Pharma International PTY LTD
- Location
- Salisbury South (AU)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs