RXQ Compounding LLC
FDA inspection history in Athens, Ohio, 2015 to 2019
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2017: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Three Form 483s and one warning letter, at Athens, Ohio.
- 2019The longest 483 on file: 14 observations over 12 pages at Athens, Ohio.
Cited most
Across all RXQ Compounding observations on file
- 21 CFR 211.42Design and construction features7
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.188(b)Batch production and control records3
- 21 CFR 211.192Production record review3
- 21 CFR 211.25Personnel qualifications3
The complete RXQ Compounding file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Athens, Ohio
Three Form 483s and one warning letter · 2015 to 2019 · 33 observations
Latest: Form 483, Jun 6, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-06 | 483 Form 483 | Athens, Ohio | 14 | $99 |
| 2017-08-08 | 483 Form 483 | Athens, Ohio | 9 | $99 |
| 2016-05-19 | Warning letter Warning letter | Athens, Ohio | — | $99 |
| 2015-09-21 | 483 Form 483 | Athens, Ohio | 10 | $99 |
Investigators on these documents
Christopher T. Middendorf (1)Jazmine N. Still (1)Joshua P. Wireman (1)Lindsey M. Schwierjohann (1)Sarah E. Rhoades (1)
FEI number 3011509553 · most recent document Jun 6, 2019
About RXQ Compounding LLC
How many FDA Form 483s has RXQ Compounding LLC received?
FDA Intel has 3 Form 483s on file for RXQ Compounding LLC; the most recent is dated Jun 6, 2019.
When was RXQ Compounding LLC last inspected by FDA?
The most recent FDA inspection document on file for RXQ Compounding LLC is a Form 483 dated Jun 6, 2019, for the site in Athens, Ohio.
What did FDA cite at RXQ Compounding LLC?
The regulations cited most in the observations on file for RXQ Compounding LLC are 21 CFR 211.42 (Design and construction features), 7 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.188(b) (Batch production and control records), 3 times.
Has RXQ Compounding LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for RXQ Compounding LLC; the most recent is dated May 19, 2016.