South Coast Specialty Compounding, Inc.
Form 483 issued March 31, 2017 · Irvine, California
- Inspection
- Mar 27 – Mar 31, 2017
- Investigators
- Roger F. Zabinski· Theresa Kirkham
- Observations
- 3
- Pages
- 3
- FEI number
- 3003436217
In short: On March 31, 2017, FDA issued a Form 483 with 3 observations to South Coast Specialty Compounding, Inc. in Irvine, California (FEI 3003436217) after an inspection that ran Mar 27 – Mar 31, 2017. The investigators were Roger F. Zabinski and Theresa Kirkham. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
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 air supply that is filtered through high-efficiency particulate air…
- 02
Complaint records are deficient in that they do not include the findings of the…
- 03
The quality control unit lacks authority to fully investigate…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
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 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected South Coast Specialty Compounding, Inc.?
Roger F. Zabinski and Theresa Kirkham are named on this Form 483, for the inspection of Mar 27 – Mar 31, 2017. Each investigator has a profile showing what they cite most.
When was South Coast Specialty Compounding, Inc. inspected by FDA?
The inspection ran Mar 27 – Mar 31, 2017, and the Form 483 is dated March 31, 2017.
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.