Compounded Solutions in Pharmacy, LLC
Form 483 issued July 27, 2021 · Monroe, Connecticut
- Inspection
- Jul 20 – Jul 27, 2021
- Investigators
- Johnna L. Bleem· Mindy M. Chou
- Observations
- 7
- Pages
- 5
- FEI number
- 3012039582
In short: On July 27, 2021, FDA issued a Form 483 with 7 observations to Compounded Solutions in Pharmacy, LLC in Monroe, Connecticut (FEI 3012039582) after an inspection that ran Jul 20 – Jul 27, 2021. The investigators were Johnna L. Bleem and Mindy M. Chou. 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 7 observations.
Most cited: 21 CFR 211.113 (2×) · 211.28 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Materials or supplies were not disinfected prior to entering…
- 02
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…
- 03
The use of sporicidal agents in the clean rooms and ISO 5 classified aseptic processing area…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Johnna L. Bleem
6 documents · 2019–2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
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.
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 Compounded Solutions in Pharmacy, LLC?
FDA listed 7 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 Compounded Solutions in Pharmacy, LLC?
Johnna L. Bleem and Mindy M. Chou are named on this Form 483, for the inspection of Jul 20 – Jul 27, 2021. Each investigator has a profile showing what they cite most.
When was Compounded Solutions in Pharmacy, LLC inspected by FDA?
The inspection ran Jul 20 – Jul 27, 2021, and the Form 483 is dated July 27, 2021.
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.