Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
Form 483 issued July 20, 2017 · Fort Myers, Florida
- Inspection
- Jul 13 – Jul 20, 2017
- Investigators
- Jennifer Lalama· June P. Page
- Observations
- 9
- Pages
- 8
- FEI number
- 3011123993
In short: On July 20, 2017, FDA issued a Form 483 with 9 observations to Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy in Fort Myers, Florida (FEI 3011123993) after an inspection that ran Jul 13 – Jul 20, 2017. The investigators were Jennifer Lalama and June P. Page. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in diug products not required to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. *** THIS…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
The flow of though the building is not…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) 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(a)
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 9 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?
Jennifer Lalama and June P. Page are named on this Form 483, for the inspection of Jul 13 – Jul 20, 2017. 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 Jul 13 – Jul 20, 2017, and the Form 483 is dated July 20, 2017.
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.