The Compounding Shop
Form 483 issued September 3, 2013 · St. Petersburg, Florida
- Inspection
- Aug 23 – Sep 3, 2013
- Investigators
- Michael H. Tollon· Nicole E. Knowlton
- Observations
- 4
- Pages
- 3
- FEI number
- 3004668624
In short: On September 3, 2013, FDA issued a Form 483 with 4 observations to The Compounding Shop in St. Petersburg, Florida (FEI 3004668624) after an inspection that ran Aug 23 – Sep 3, 2013. The investigators were Michael H. Tollon and Nicole E. Knowlton. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or…
- 02
Complaint records are deficient in that they do not include the findings of…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Michael H. Tollon
12 documents · 2013–2024
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Compounding Shop?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected The Compounding Shop?
Michael H. Tollon and Nicole E. Knowlton are named on this Form 483, for the inspection of Aug 23 – Sep 3, 2013. Each investigator has a profile showing what they cite most.
When was The Compounding Shop inspected by FDA?
The inspection ran Aug 23 – Sep 3, 2013, and the Form 483 is dated September 3, 2013.
How do I get the full Form 483 for The Compounding Shop?
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.