BioChem Sioux City Inc.
FDA inspection history in Sioux City, Iowa, 2021 to 2026
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Sioux City, Iowa.
- 2021The longest 483 on file: 5 observations over 4 pages at Sioux City, Iowa.
- 2026One Form 483, at Sioux City, Iowa.
Cited most
Across all BioChem Sioux City observations on file
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.194Laboratory records1
The complete BioChem Sioux City file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Sioux City, Iowa
Two Form 483s · 2021 to 2026 · 7 observations
Latest: Form 483, Mar 19, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-19 | 483 Form 483 | Sioux City, Iowa | 2 | $99 |
| 2021-08-06 | 483 Form 483 | Sioux City, Iowa | 5 | $99 |
Investigators on these documents
Carolina D. Vasquez (1)Matthew B. Casale (1)Matthew Schuckmann (1)
FEI number 1910218 · most recent document Mar 19, 2026
About BioChem Sioux City Inc.
How many FDA Form 483s has BioChem Sioux City Inc. received?
FDA Intel has 2 Form 483s on file for BioChem Sioux City Inc.; the most recent is dated Mar 19, 2026.
When was BioChem Sioux City Inc. last inspected by FDA?
The most recent FDA inspection document on file for BioChem Sioux City Inc. is a Form 483 dated Mar 19, 2026, for the site in Sioux City, Iowa.
What did FDA cite at BioChem Sioux City Inc.?
The regulations cited most in the observations on file for BioChem Sioux City Inc. are 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.