Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
Form 483 issued February 9, 2020 · Fort Myers, Florida
- Inspection
- Feb 9, 2020
- Investigators
- Jennifer L. Huntington· Saundrea A. Munroe
- Observations
- 3
- Pages
- 4
- FEI number
- 3011123993
In short: On February 9, 2020, FDA issued a Form 483 with 3 observations to Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy in Fort Myers, Florida (FEI 3011123993) after an inspection that ran Feb 9, 2020. The investigators were Jennifer L. Huntington and Saundrea A. Munroe. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel manually contacted the inner surface of…
- 02
You did not make adequate product evaluation and take remedial action w here actionable microbial contamination…
- 03
Procedures designed to prevent insanitary conditions are…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
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
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 3 observations on this Form 483, mostly about production. 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 L. Huntington and Saundrea A. Munroe are named on this Form 483, for the inspection of Feb 9, 2020. 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 Feb 9, 2020, and the Form 483 is dated February 9, 2020.
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.