Clinical Specialties Compounding Pharmacy
Form 483 issued April 2, 2013 · Augusta, Georgia
- Inspection
- Mar 18 – Apr 2, 2013
- Investigators
- Jawaid Hamid· Lareese K. Thomas· Nicole A. Lloyd
- Observations
- 11
- Pages
- 8
- FEI number
- 3010078541
In short: On April 2, 2013, FDA issued a Form 483 with 11 observations to Clinical Specialties Compounding Pharmacy in Augusta, Georgia (FEI 3010078541) after an inspection that ran Mar 18 – Apr 2, 2013. The investigators were Jawaid Hamid, Lareese K. Thomas and Nicole A. Lloyd. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Jawaid Hamid
1 document · 2013
Cites 211.42(b) (design and construction features) more than any other section. Most of their documents are for sites in Georgia.
The firmClinical Specialties Compounding Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Clinical Specialties Compounding Pharmacy?
FDA listed 11 observations on this Form 483, mostly about laboratory controls, facilities & equipment 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 Clinical Specialties Compounding Pharmacy?
Jawaid Hamid, Lareese K. Thomas and Nicole A. Lloyd are named on this Form 483, for the inspection of Mar 18 – Apr 2, 2013. Each investigator has a profile showing what they cite most.
When was Clinical Specialties Compounding Pharmacy inspected by FDA?
The inspection ran Mar 18 – Apr 2, 2013, and the Form 483 is dated April 2, 2013.
How do I get the full Form 483 for Clinical Specialties Compounding Pharmacy?
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.