Has Apotek Production & Laboratorier AB had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Apotek Production & Laboratorier AB so far. Argus ingests new FDA records daily.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3003766921.

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.

Where can I read the full Form 483?

The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.

FDA Form 483 — Apotek Production & Laboratorier AB (January 29, 2026)

Key facts

Firm	Apotek Production & Laboratorier AB
FEI / inspection ID	3003766921
Inspection end date	January 29, 2026
Citation count	1

Key takeaway: FDA inspected Apotek Production & Laboratorier AB in Sweden and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2026-01-29. FDA records classify Apotek Production & Laboratorier AB as a sterile drug manufacturer. 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.

Citations explained

Observation 1 — -- 1 of 7 -- -- 2 of 7 -- -- 3

-- 1 of 7 -- -- 2 of 7 -- -- 3 of 7 -- -- 4 of 7 -- -- 5 of 7 -- -- 6 of 7 -- -- 7 of 7 --

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.

Apotek Production & Laboratorier AB’s FDA history

Argus HQ has recorded 1 total FDA action tied to Apotek Production & Laboratorier AB: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

Has Apotek Production & Laboratorier AB had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Apotek Production & Laboratorier AB so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3003766921.
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.
Where can I read the full Form 483?: The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.

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 Apotek Production & Laboratorier AB

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 Form 483 — Apotek Production & Laboratorier AB (January 29, 2026) — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-apotek-production-and-laboratorier-ab-2026-01-29-3003766921

MLA

"FDA Form 483 — Apotek Production & Laboratorier AB (January 29, 2026) — 1 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-apotek-production-and-laboratorier-ab-2026-01-29-3003766921.

Chicago

Argus HQ Research. "FDA Form 483 — Apotek Production & Laboratorier AB (January 29, 2026) — 1 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-apotek-production-and-laboratorier-ab-2026-01-29-3003766921.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_apotek_production_and_laboratorier_ab_2026_01_29_3003766921_2026,
  title = {FDA Form 483 — Apotek Production & Laboratorier AB (January 29, 2026) — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-apotek-production-and-laboratorier-ab-2026-01-29-3003766921},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗