South Coast Specialty Compounding, Inc.
Form 483 issued March 14, 2016 · Irvine, California
- Inspection
- Feb 23 – Mar 14, 2016
- Investigators
- Binh T. Nguyen· Darren S. Brown· Saied A. Asbagh
- Observations
- 8
- Pages
- 9
- FEI number
- 3003436217
In short: On March 14, 2016, FDA issued a Form 483 with 8 observations to South Coast Specialty Compounding, Inc. in Irvine, California (FEI 3003436217) after an inspection that ran Feb 23 – Mar 14, 2016. The investigators were Binh T. Nguyen, Darren S. Brown and Saied A. Asbagh. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Binh T. Nguyen
13 documents · 2009–2016
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 211.113(b)
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 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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.?
Binh T. Nguyen, Darren S. Brown and Saied A. Asbagh are named on this Form 483, for the inspection of Feb 23 – Mar 14, 2016. Each investigator has a profile showing what they cite most.
When was South Coast Specialty Compounding, Inc. inspected by FDA?
The inspection ran Feb 23 – Mar 14, 2016, and the Form 483 is dated March 14, 2016.
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.