What happens after a Form 483 is issued?

The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.

Has BioChem Sioux City, Inc. had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for BioChem Sioux City, Inc. so far. Argus ingests new FDA records daily.

Is a Form 483 the same as a Warning Letter?

No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

FDA Inspects BioChem Sioux City, Inc.: Form 483 with 1 Citations (March 19, 2026)

At a glance: FDA inspected BioChem Sioux City, Inc. in Iowa, USA and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2026-03-19. FDA records classify BioChem Sioux City, Inc. as a heparin sodium crude manufacture. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

Key facts

Firm	BioChem Sioux City, Inc.
FEI / inspection ID	1910218
Inspection end date	March 19, 2026
Citation count	1

Citations explained

Observation 1 — -- 1 of 2 -- -- 2 of 2

-- 1 of 2 -- -- 2 of 2 -- A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it. A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.

What a Form 483 means

A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.

BioChem Sioux City, Inc.’s FDA history

Argus HQ has recorded 1 total FDA action tied to BioChem Sioux City, Inc.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What happens after a Form 483 is issued?: The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
Has BioChem Sioux City, Inc. had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for BioChem Sioux City, Inc. so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 1910218.
Is a Form 483 the same as a Warning Letter?: No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

See if this 483 escalates to a warning letter — before your auditor asks.

Free weekly briefing tracks every FDA inspection outcome.

Full FDA history for BioChem Sioux City, Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Inspects BioChem Sioux City, Inc.: Form 483 with 1 Citations (March 19, 2026). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/biochem-sioux-city-1910218-2026-03-19

MLA

"FDA Inspects BioChem Sioux City, Inc.: Form 483 with 1 Citations (March 19, 2026)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/biochem-sioux-city-1910218-2026-03-19.

Chicago

Argus HQ Research. "FDA Inspects BioChem Sioux City, Inc.: Form 483 with 1 Citations (March 19, 2026)." Digital Empire Holdings LLC. Accessed August 17, 2026. https://argushq.ai/483/biochem-sioux-city-1910218-2026-03-19.

BibTeX

@misc{argushq_argushq_ai_483_biochem_sioux_city_1910218_2026_03_19_2026,
  title = {FDA Inspects BioChem Sioux City, Inc.: Form 483 with 1 Citations (March 19, 2026)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/biochem-sioux-city-1910218-2026-03-19},
  note = {Accessed: August 17, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗