STAQ Pharma of Ohio, LLC
Form 483 issued May 16, 2025 · Columbus, Ohio
- Inspection
- May 6 – May 16, 2025
- Investigators
- Claude Noel Y. Zanetsie· Tekalign Wondimu· Yaham Su
- Observations
- 3
- Pages
- 4
- FEI number
- 3025336457
In short: On May 16, 2025, FDA issued a Form 483 with 3 observations to STAQ Pharma of Ohio, LLC in Columbus, Ohio (FEI 3025336457) after an inspection that ran May 6 – May 16, 2025. The investigators were Claude Noel Y. Zanetsie, Tekalign Wondimu and Yaham Su. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Your fum failed to establish adequate written procedures for production and process controls designed to assure…
- 03FDCA 503B(a)(10)(A)
Observation 3: scanned text, readable in the full document.
This inspection in context
Claude Noel Y. Zanetsie
3 documents · 2004–2025
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in New Jersey.
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 211.192
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 3 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected STAQ Pharma of Ohio, LLC?
Claude Noel Y. Zanetsie, Tekalign Wondimu and Yaham Su are named on this Form 483, for the inspection of May 6 – May 16, 2025. Each investigator has a profile showing what they cite most.
When was STAQ Pharma of Ohio, LLC inspected by FDA?
The inspection ran May 6 – May 16, 2025, and the Form 483 is dated May 16, 2025.
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.