RXQ Compounding LLC
Form 483 issued June 6, 2019 · Athens, Ohio
- Inspection
- May 6 – Jun 6, 2019
- Investigators
- Jazmine N. Still· Sarah E. Rhoades
- Observations
- 14
- Pages
- 12
- FEI number
- 3011509553
In short: On June 6, 2019, FDA issued a Form 483 with 14 observations to RXQ Compounding LLC in Athens, Ohio (FEI 3011509553) after an inspection that ran May 6 – Jun 6, 2019. The investigators were Jazmine N. Still and Sarah E. Rhoades. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 9 of 14 observations.
Most cited: 21 CFR 211.42 (3×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Jazmine N. Still
16 documents · 2017–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RXQ Compounding LLC?
FDA listed 14 observations on this Form 483, mostly about facilities & equipment, quality system 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 RXQ Compounding LLC?
Jazmine N. Still and Sarah E. Rhoades are named on this Form 483, for the inspection of May 6 – Jun 6, 2019. Each investigator has a profile showing what they cite most.
When was RXQ Compounding LLC inspected by FDA?
The inspection ran May 6 – Jun 6, 2019, and the Form 483 is dated June 6, 2019.
How do I get the full Form 483 for RXQ Compounding 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.