Compounded Solutions in Pharmacy, LLC
Form 483 issued August 29, 2019 · Monroe, Connecticut
- Inspection
- Aug 6 – Aug 29, 2019
- Investigator
- John P. Mistler
- Observations
- 9
- Pages
- 8
- FEI number
- 3012039582
In short: On August 29, 2019, FDA issued a Form 483 with 9 observations to Compounded Solutions in Pharmacy, LLC in Monroe, Connecticut (FEI 3012039582) after an inspection that ran Aug 6 – Aug 29, 2019. The investigator was John P. Mistler. Most observations concern materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Observations span 1 system, led by materials.
Most cited: FDCA 501(a)(2)(A) (8×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You used a non-pharmaceutical grade component in the formulation…
- 02FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly…
- 03FDCA 501(a)(2)(A)
Non-microbial contamination was observed…
- 04FDCA 501(a)(2)(A)
Unsealed, loose ceiling tiles were…
This inspection in context
John P. Mistler
15 documents · 2015–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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.
Similar 483sOther sites cited under 211.80
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 9 observations on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Compounded Solutions in Pharmacy, LLC?
John P. Mistler is named on this Form 483, for the inspection of Aug 6 – Aug 29, 2019. Each investigator has a profile showing what they cite most.
When was Compounded Solutions in Pharmacy, LLC inspected by FDA?
The inspection ran Aug 6 – Aug 29, 2019, and the Form 483 is dated August 29, 2019.
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.