Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
Form 483 issued August 9, 2022 · Fort Myers, Florida
- Inspection
- Aug 2 – Aug 9, 2022
- Investigators
- Jennifer Lalama· Steven A. Brettler
- Observations
- 2
- Pages
- 3
- FEI number
- 3011123993
In short: On August 9, 2022, FDA issued a Form 483 with 2 observations to Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy in Fort Myers, Florida (FEI 3011123993) after an inspection that ran Aug 2 – Aug 9, 2022. The investigators were Jennifer Lalama and Steven A. Brettler.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02FDCA 501(a)(2)(A)
The (b) <4 > intended to render fmal product sterile was 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.
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Questions about this 483
What did FDA find at Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy?
FDA listed 2 observations on this Form 483. 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 Steven A. Brettler are named on this Form 483, for the inspection of Aug 2 – Aug 9, 2022. 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 Aug 2 – Aug 9, 2022, and the Form 483 is dated August 9, 2022.
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.