BioChem Sioux City Inc.
Form 483 issued August 6, 2021 · Sioux City, Iowa
- Inspection
- Aug 3 – Aug 6, 2021
- Investigators
- Matthew B. Casale· Matthew Schuckmann
- Observations
- 5
- Pages
- 4
- FEI number
- 1910218
In short: On August 6, 2021, FDA issued a Form 483 with 5 observations to BioChem Sioux City Inc. in Sioux City, Iowa (FEI 1910218) after an inspection that ran Aug 3 – Aug 6, 2021. The investigators were Matthew B. Casale and Matthew Schuckmann. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and production account for 3 of 5 observations.
Most cited: 21 CFR 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Crude Heparin Sodium is not adequately protected from contamination as…
- 02
Employees are making product release decisions without adequate…
- 03
The only testing for (Bb) (4) performed on Crude Heparin Sodium produced at the Sioux City…
- 04
The only testing for (b) (4) performed on Crude Heparin Sodium produced at the Sioux City…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioChem Sioux City Inc.?
FDA listed 5 observations on this Form 483, mostly about materials, production and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected BioChem Sioux City Inc.?
Matthew B. Casale and Matthew Schuckmann are named on this Form 483, for the inspection of Aug 3 – Aug 6, 2021. Each investigator has a profile showing what they cite most.
When was BioChem Sioux City Inc. inspected by FDA?
The inspection ran Aug 3 – Aug 6, 2021, and the Form 483 is dated August 6, 2021.
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.