WILD CHILD LABORATORIES PTY LTD
Form 483 issued June 21, 2024 · Osborne Park, Australia
- Inspection
- Jun 17 – Jun 21, 2024
- Investigator
- Anastasia M. Shields
- Observations
- 7
- Pages
- 7
- FEI number
- 3006210769
In short: On June 21, 2024, FDA issued a Form 483 with 7 observations to WILD CHILD LABORATORIES PTY LTD in Osborne Park, WESTERN AUSTRALIA (FEI 3006210769) after an inspection that ran Jun 17 – Jun 21, 2024. The investigator was Anastasia M. Shields. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
The written stability program for drug products does not…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmWILD CHILD LABORATORIES PTY LTD history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WILD CHILD LABORATORIES PTY LTD?
FDA listed 7 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected WILD CHILD LABORATORIES PTY LTD?
Anastasia M. Shields is named on this Form 483, for the inspection of Jun 17 – Jun 21, 2024. Each investigator has a profile showing what they cite most.
When was WILD CHILD LABORATORIES PTY LTD inspected by FDA?
The inspection ran Jun 17 – Jun 21, 2024, and the Form 483 is dated June 21, 2024.
How do I get the full Form 483 for WILD CHILD LABORATORIES 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.