Compounded Solutions in Pharmacy, LLC
Form 483 issued August 23, 2023 · Monroe, Connecticut
- Inspection
- Aug 1 – Aug 23, 2023
- Investigator
- Robert J. Martin
- Observations
- 3
- Pages
- 3
- FEI number
- 3012039582
In short: On August 23, 2023, FDA issued a Form 483 with 3 observations to Compounded Solutions in Pharmacy, LLC in Monroe, Connecticut (FEI 3012039582) after an inspection that ran Aug 1 – Aug 23, 2023. The investigator was Robert J. Martin.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Personnel were observed moving quickly in a critical area or in an area immediately adjacent to…
- 02FDCA 501(a)(2)(A)
Smoke studies were inadequately…
- 03FDCA 501(a)(2)(A)
Sterile diugs were exposed to lower than…
This inspection in context
Robert J. Martin
29 documents · 2014–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmCompounded Solutions in Pharmacy, LLC history
All 5 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 Compounded Solutions in Pharmacy, LLC?
FDA listed 3 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Compounded Solutions in Pharmacy, LLC?
Robert J. Martin is named on this Form 483, for the inspection of Aug 1 – Aug 23, 2023. Each investigator has a profile showing what they cite most.
When was Compounded Solutions in Pharmacy, LLC inspected by FDA?
The inspection ran Aug 1 – Aug 23, 2023, and the Form 483 is dated August 23, 2023.
How do I get the full Form 483 for Compounded Solutions in Pharmacy, LLC?
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.