STAQ Pharma of Ohio, LLC
Form 483 issued August 19, 2026 · Columbus, Ohio
- Inspection
- Aug 10 – Aug 19, 2026
- Investigators
- Anna M. Spiros· Lisa R. Hilliard· Supreet K. Sran
- Observations
- 3
- Pages
- 5
- FEI number
- 3025336457
In short: On August 19, 2026, FDA issued a Form 483 with 3 observations to STAQ Pharma of Ohio, LLC in Columbus, Ohio (FEI 3025336457) after an inspection that ran Aug 10 – Aug 19, 2026. The investigators were Anna M. Spiros, Lisa R. Hilliard and Supreet K. Sran. Most observations concern production and laboratory controls.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 02
Batch production and control records do not include in-process results for each batch…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Anna M. Spiros
6 documents · 2024–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Michigan.
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 211.160
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 production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected STAQ Pharma of Ohio, LLC?
Anna M. Spiros, Lisa R. Hilliard and Supreet K. Sran are named on this Form 483, for the inspection of Aug 10 – Aug 19, 2026. Each investigator has a profile showing what they cite most.
When was STAQ Pharma of Ohio, LLC inspected by FDA?
The inspection ran Aug 10 – Aug 19, 2026, and the Form 483 is dated August 19, 2026.
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.