RXQ Compounding LLC
Form 483 issued August 8, 2017 · Athens, Ohio
- Inspection
- Jul 11 – Aug 8, 2017
- Investigator
- Lindsey M. Schwierjohann
- Observations
- 9
- Pages
- 8
- FEI number
- 3011509553
In short: On August 8, 2017, FDA issued a Form 483 with 9 observations to RXQ Compounding LLC in Athens, Ohio (FEI 3011509553) after an inspection that ran Jul 11 – Aug 8, 2017. The investigator was Lindsey M. Schwierjohann. 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 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Time limits are not established when appropriate for the completion of each production phase to assure…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Lindsey M. Schwierjohann
6 documents · 2015–2019
Cites 211.188 (batch production and control records) 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 211.111
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RXQ Compounding LLC?
FDA listed 9 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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?
Lindsey M. Schwierjohann is named on this Form 483, for the inspection of Jul 11 – Aug 8, 2017. Each investigator has a profile showing what they cite most.
When was RXQ Compounding LLC inspected by FDA?
The inspection ran Jul 11 – Aug 8, 2017, and the Form 483 is dated August 8, 2017.
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.