STAQ Pharma of Ohio, LLC
Form 483 issued October 4, 2023 · Columbus, Ohio
- Inspection
- Sep 18 – Oct 4, 2023
- Investigator
- Andrew J. Barrowcliff
- Observations
- 2
- Pages
- 3
- FEI number
- 3025336457
In short: On October 4, 2023, FDA issued a Form 483 with 2 observations to STAQ Pharma of Ohio, LLC in Columbus, Ohio (FEI 3025336457) after an inspection that ran Sep 18 – Oct 4, 2023. The investigator was Andrew J. Barrowcliff. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (1×) · 211.42(c)(10)(iv) (1×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case…
- 02
Aseptic processing areas are deficient regarding the system…
This inspection in context
Andrew J. Barrowcliff
5 documents · 2018–2023
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmSTAQ Pharma of Ohio, 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(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at STAQ Pharma of Ohio, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. 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 STAQ Pharma of Ohio, LLC?
Andrew J. Barrowcliff is named on this Form 483, for the inspection of Sep 18 – Oct 4, 2023. Each investigator has a profile showing what they cite most.
When was STAQ Pharma of Ohio, LLC inspected by FDA?
The inspection ran Sep 18 – Oct 4, 2023, and the Form 483 is dated October 4, 2023.
How do I get the full Form 483 for STAQ Pharma of Ohio, 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.