Mayne Pharma International Pty Ltd.
Form 483 issued October 18, 2019 · Salisbury South, Australia
- Inspection
- Oct 14 – Oct 18, 2019
- Observations
- 1
- Pages
- 1
- FEI number
- 3004090027
In short: On October 18, 2019, FDA issued a Form 483 with 1 observation to Mayne Pharma International Pty Ltd. in Salisbury South, South Australia (FEI 3004090027) after an inspection that ran Oct 14 – Oct 18, 2019. Most observations concern quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Individuals responsible for supervising the manufacture of a drug product lack the experience to perform their…
This inspection in context
Questions about this 483
What did FDA find at Mayne Pharma International Pty Ltd.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
When was Mayne Pharma International Pty Ltd. inspected by FDA?
The inspection ran Oct 14 – Oct 18, 2019, and the Form 483 is dated October 18, 2019.
How do I get the full Form 483 for Mayne Pharma International Pty Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.