The Compounding Shop
Form 483 issued March 25, 2013 · St Petersburg, Florida
- Inspection
- Mar 18 – Mar 22, 2013
- Investigators
- Ileana Barreto-Pettit· Nicholas P. Diorio
- Observations
- 12
- Pages
- 10
- FEI number
- 3004668624
In short: On March 25, 2013, FDA issued a Form 483 with 12 observations to The Compounding Shop in St Petersburg, Florida (FEI 3004668624) after an inspection that ran Mar 18 – Mar 22, 2013. The investigators were Ileana Barreto-Pettit and Nicholas P. Diorio. 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 8 of 12 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 04
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmThe Compounding Shop 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 The Compounding Shop?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 The Compounding Shop?
Ileana Barreto-Pettit and Nicholas P. Diorio are named on this Form 483, for the inspection of Mar 18 – Mar 22, 2013. Each investigator has a profile showing what they cite most.
When was The Compounding Shop inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2013, and the Form 483 is dated March 25, 2013.
How do I get the full Form 483 for The Compounding Shop?
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