RXQ Compounding LLC
Form 483 issued September 21, 2015 · Athens, Ohio
- Inspection
- Aug 24 – Sep 21, 2015
- Investigators
- Christopher T. Middendorf· Joshua P. Wireman
- Observations
- 10
- Pages
- 6
- FEI number
- 3011509553
In short: On September 21, 2015, FDA issued a Form 483 with 10 observations to RXQ Compounding LLC in Athens, Ohio (FEI 3011509553) after an inspection that ran Aug 24 – Sep 21, 2015. The investigators were Christopher T. Middendorf and Joshua P. Wireman. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 6 of 10 observations.
Most cited: 21 CFR 211.167(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Clothing of personnel engaged in the manufacturing of drug products is not appropriate for…
This inspection in context
Christopher T. Middendorf
8 documents · 2011–2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmRXQ Compounding LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.167(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RXQ Compounding LLC?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 RXQ Compounding LLC?
Christopher T. Middendorf and Joshua P. Wireman are named on this Form 483, for the inspection of Aug 24 – Sep 21, 2015. Each investigator has a profile showing what they cite most.
When was RXQ Compounding LLC inspected by FDA?
The inspection ran Aug 24 – Sep 21, 2015, and the Form 483 is dated September 21, 2015.
How do I get the full Form 483 for RXQ Compounding LLC?
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