World Club Supply Corp
Form 483 issued August 18, 2016 · Orange, California
- Inspection
- Aug 16 – Aug 18, 2016
- Investigator
- Chelsea N. Sealey
- Observations
- 12
- Pages
- 9
- FEI number
- 3002690301
In short: On August 18, 2016, FDA issued a Form 483 with 12 observations to World Club Supply Corp in Orange, California (FEI 3002690301) after an inspection that ran Aug 16 – Aug 18, 2016. The investigator was Chelsea N. Sealey. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Chelsea N. Sealey
4 documents · 2015–2016
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmWorld Club Supply Corp history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at World Club Supply Corp?
FDA listed 12 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected World Club Supply Corp?
Chelsea N. Sealey is named on this Form 483, for the inspection of Aug 16 – Aug 18, 2016. Each investigator has a profile showing what they cite most.
When was World Club Supply Corp inspected by FDA?
The inspection ran Aug 16 – Aug 18, 2016, and the Form 483 is dated August 18, 2016.
How do I get the full Form 483 for World Club Supply Corp?
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.