Custom Compounding Centers, LLC
Form 483 issued August 28, 2014 · Los Alamitos, California
- Inspection
- Aug 4 – Aug 28, 2014
- Investigator
- Joey V. Quitania
- Observations
- 3
- Pages
- 2
- FEI number
- 3009855773
In short: On August 28, 2014, FDA issued a Form 483 with 3 observations to Custom Compounding Centers, LLC in Los Alamitos, California (FEI 3009855773) after an inspection that ran Aug 4 – Aug 28, 2014. The investigator was Joey V. Quitania. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested through…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmCustom Compounding Centers, LLC history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Compounding Centers, LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Custom Compounding Centers, LLC?
Joey V. Quitania is named on this Form 483, for the inspection of Aug 4 – Aug 28, 2014. Each investigator has a profile showing what they cite most.
When was Custom Compounding Centers, LLC inspected by FDA?
The inspection ran Aug 4 – Aug 28, 2014, and the Form 483 is dated August 28, 2014.
How do I get the full Form 483 for Custom Compounding Centers, LLC?
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.