Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
Form 483 issued December 22, 2014 · Fort Myers, Florida
- Inspection
- Dec 1 – Dec 22, 2014
- Investigator
- Michael H. Tollon
- Observations
- 10
- Pages
- 7
- FEI number
- 3011123993
In short: On December 22, 2014, FDA issued a Form 483 with 10 observations to Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy in Fort Myers, Florida (FEI 3011123993) after an inspection that ran Dec 1 – Dec 22, 2014. The investigator was Michael H. Tollon. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 6 of 10 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 do not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
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 firmInfusion Systems of SW Florida Inc. dba Myerlee Pharmacy history
All 4 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 Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy?
Michael H. Tollon is named on this Form 483, for the inspection of Dec 1 – Dec 22, 2014. Each investigator has a profile showing what they cite most.
When was Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy inspected by FDA?
The inspection ran Dec 1 – Dec 22, 2014, and the Form 483 is dated December 22, 2014.
How do I get the full Form 483 for Infusion Systems of SW Florida Inc. dba Myerlee 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.