Compounded Solutions in Pharmacy, LLC
FDA inspection history in Monroe, Connecticut, 2017 to 2023
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one warning letter and one Form 483; 2019: one Form 483; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–23Four Form 483s and one warning letter, at Monroe, Connecticut.
- 2019The longest 483 on file: 9 observations over 8 pages at Monroe, Connecticut.
Cited most
Across all Compounded Solutions in Pharmacy observations on file
- FDCA 501(a)(2)(A)Insanitary conditions11
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.28Personnel responsibilities3
- 21 CFR 211.67Equipment cleaning and maintenance2
The complete Compounded Solutions in Pharmacy file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Monroe, Connecticut
Four Form 483s and one warning letter · 2017 to 2023 · 24 observations
Latest: Form 483, Aug 23, 2023 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-23 | 483 Form 483 | Monroe, Connecticut | 3 | $99 |
| 2021-07-27 | 483 Form 483 | Monroe, Connecticut | 7 | $99 |
| 2019-08-29 | 483 Form 483 | Monroe, Connecticut | 9 | $99 |
| 2017-09-18 | Warning letter Warning letter | Monroe, Connecticut | — | $99 |
| 2017-03-03 | 483 Form 483 | Monroe, Connecticut | 5 | $99 |
Investigators on these documents
Christopher Janik (1)Diem N. Nguyen (1)John P. Mistler (1)Johnna L. Bleem (1)Mindy M. Chou (1)Nealie C. Newberger (1)Robert J. Martin (1)
FEI number 3012039582 · most recent document Aug 23, 2023
About Compounded Solutions in Pharmacy, LLC
How many FDA Form 483s has Compounded Solutions in Pharmacy, LLC received?
FDA Intel has 4 Form 483s on file for Compounded Solutions in Pharmacy, LLC; the most recent is dated Aug 23, 2023.
When was Compounded Solutions in Pharmacy, LLC last inspected by FDA?
The most recent FDA inspection document on file for Compounded Solutions in Pharmacy, LLC is a Form 483 dated Aug 23, 2023, for the site in Monroe, Connecticut.
What did FDA cite at Compounded Solutions in Pharmacy, LLC?
The regulations cited most in the observations on file for Compounded Solutions in Pharmacy, LLC are FDCA 501(a)(2)(A) (Insanitary conditions), 11 times; 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times.
Has Compounded Solutions in Pharmacy, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Compounded Solutions in Pharmacy, LLC; the most recent is dated Sep 18, 2017.