BioChem Sioux City Inc.
Form 483 issued March 19, 2026 · Sioux City, Iowa
- Inspection
- Mar 17 – Mar 19, 2026
- Investigator
- Carolina D. Vasquez
- Observations
- 2
- Pages
- 2
- FEI number
- 1910218
In short: On March 19, 2026, FDA issued a Form 483 with 2 observations to BioChem Sioux City Inc. in Sioux City, Iowa (FEI 1910218) after an inspection that ran Mar 17 – Mar 19, 2026. The investigator was Carolina D. Vasquez. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166 (1×) · 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm has not established an ongoing stability program for heparin sodium crude (b) (4) to…
- 02
The firm follows procedure AMB-101355, BioChem WI: Heparin Sodium (b) (4) Assay, version 7. 0, effective…
This inspection in context
Carolina D. Vasquez
9 documents · 2022–2026
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in California.
The firmBioChem Sioux City Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioChem Sioux City Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected BioChem Sioux City Inc.?
Carolina D. Vasquez is named on this Form 483, for the inspection of Mar 17 – Mar 19, 2026. Each investigator has a profile showing what they cite most.
When was BioChem Sioux City Inc. inspected by FDA?
The inspection ran Mar 17 – Mar 19, 2026, and the Form 483 is dated March 19, 2026.
How do I get the full Form 483 for BioChem Sioux City Inc.?
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.