In short: On November 3, 2020, FDA issued a Form 483 with 9 observations to World Club Supply Corp in Orange, California (FEI 3002690301) after an inspection that ran Oct 27 – Nov 3, 2020. The investigators were Kb Mun and Lisa Shin. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.100(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and…
- 03
The batch production and control records are deficient in that they do not include documentation of…
- 04
Written records of investigations into do not include…
This inspection in context
Kb Mun
1 document · 2020
Cites 211.100(a) (written procedures; deviations) 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 211.100(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 9 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected World Club Supply Corp?
Kb Mun and Lisa Shin are named on this Form 483, for the inspection of Oct 27 – Nov 3, 2020. Each investigator has a profile showing what they cite most.
When was World Club Supply Corp inspected by FDA?
The inspection ran Oct 27 – Nov 3, 2020, and the Form 483 is dated November 3, 2020.
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.