Parnell Manufacturing Pty Ltd
Form 483 issued September 17, 2024 · Alexandria, Australia
- Inspection
- Sep 9 – Sep 17, 2024
- Observations
- 4
- Pages
- 4
- FEI number
- 3003245034
In short: On September 17, 2024, FDA issued a Form 483 with 4 observations to Parnell Manufacturing Pty Ltd in Alexandria, NSW (FEI 3003245034) after an inspection that ran Sep 9 – Sep 17, 2024. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
(b) (4) processing areas are deficient regarding the system for cleaning and disinfecting the room and…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
This inspection in context
Questions about this 483
What did FDA find at Parnell Manufacturing Pty Ltd?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
When was Parnell Manufacturing Pty Ltd inspected by FDA?
The inspection ran Sep 9 – Sep 17, 2024, and the Form 483 is dated September 17, 2024.
How do I get the full Form 483 for Parnell Manufacturing 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.