South Coast Specialty Compounding, Inc.
Form 483 issued July 2, 2014 · Irvine, California
- Inspection
- Jun 23 – Jul 2, 2014
- Investigators
- Caryn M. McNab· Jennifer M. Gogley
- Observations
- 7
- Pages
- 4
- FEI number
- 3003436217
In short: On July 2, 2014, FDA issued a Form 483 with 7 observations to South Coast Specialty Compounding, Inc. in Irvine, California (FEI 3003436217) after an inspection that ran Jun 23 – Jul 2, 2014. The investigators were Caryn M. McNab and Jennifer M. Gogley. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and facilities & equipment account for 5 of 7 observations.
Most cited: 21 CFR 211.42 (2×) · 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
This inspection in context
Caryn M. McNab
7 documents · 2013–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmSouth Coast Specialty Compounding, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at South Coast Specialty Compounding, Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected South Coast Specialty Compounding, Inc.?
Caryn M. McNab and Jennifer M. Gogley are named on this Form 483, for the inspection of Jun 23 – Jul 2, 2014. Each investigator has a profile showing what they cite most.
When was South Coast Specialty Compounding, Inc. inspected by FDA?
The inspection ran Jun 23 – Jul 2, 2014, and the Form 483 is dated July 2, 2014.
How do I get the full Form 483 for South Coast Specialty Compounding, Inc.?
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.