WILD CHILD LABORATORIES PTY LTD
Form 483 issued May 31, 2019 · Osborne Park, Australia
- Inspection
- May 27 – May 31, 2019
- Investigator
- Unnee Ranjan
- Observations
- 5
- Pages
- 5
- FEI number
- 3006210769
In short: On May 31, 2019, FDA issued a Form 483 with 5 observations to WILD CHILD LABORATORIES PTY LTD in Osborne Park, WESTERN AUSTRALIA (FEI 3006210769) after an inspection that ran May 27 – May 31, 2019. The investigator was Unnee Ranjan. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Unnee Ranjan
30 documents · 2015–2026
Cites 211.67 (equipment cleaning and maintenance) 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 211.22(d)
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 5 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected WILD CHILD LABORATORIES PTY LTD?
Unnee Ranjan is named on this Form 483, for the inspection of May 27 – May 31, 2019. Each investigator has a profile showing what they cite most.
When was WILD CHILD LABORATORIES PTY LTD inspected by FDA?
The inspection ran May 27 – May 31, 2019, and the Form 483 is dated May 31, 2019.
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.