Compounded Solutions in Pharmacy, LLC
Form 483 issued March 3, 2017 · Monroe, Connecticut
- Inspection
- Feb 22 – Mar 3, 2017
- Investigators
- Christopher Janik· Diem N. Nguyen· Nealie C. Newberger
- Observations
- 5
- Pages
- 3
- FEI number
- 3012039582
In short: On March 3, 2017, FDA issued a Form 483 with 5 observations to Compounded Solutions in Pharmacy, LLC in Monroe, Connecticut (FEI 3012039582) after an inspection that ran Feb 22 – Mar 3, 2017. The investigators were Christopher Janik, Diem N. Nguyen and Nealie C. Newberger. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
4 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Clothing ofpersonnel engaged in the manufacture of drug products is not appropriate for…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient in that ceilings are not smooth and/or hard surfaces that…
- 04
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Christopher Janik
2 documents · 2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
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 211.42
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 5 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Compounded Solutions in Pharmacy, LLC?
Christopher Janik, Diem N. Nguyen and Nealie C. Newberger are named on this Form 483, for the inspection of Feb 22 – Mar 3, 2017. Each investigator has a profile showing what they cite most.
When was Compounded Solutions in Pharmacy, LLC inspected by FDA?
The inspection ran Feb 22 – Mar 3, 2017, and the Form 483 is dated March 3, 2017.
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.