What is an FDA Form 483?

A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.

Does this Form 483 mean Samsung Bioepis Co. Ltd. violated the law?

No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.

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 Samsung Bioepis Co. Ltd. had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Samsung Bioepis Co. Ltd. so far. Argus ingests new FDA records daily.

November 22, 2024 FDA Form 483 for Samsung Bioepis Co. Ltd.

Here's the summary: FDA inspected Samsung Bioepis Co. Ltd. in The Republic of Korea and issued a Form 483 listing 2 inspectional observations following an inspection that concluded 2024-11-22. FDA records classify Samsung Bioepis Co. Ltd. as a control testing laboratory. 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	Samsung Bioepis Co. Ltd.
FEI / inspection ID	3010031951
Inspection end date	November 22, 2024
Citation count	2

Citations explained

Observation 1 — Procedures describ ing the handling of written and oral complaints related to

Procedures describ ing the handling of written and oral complaints related to dtu g products are n ot written and/or fo llowed. Specifically, A. Your complaint handling procedure, SOP-GxP-CML-00944 Version 13.0 Product Quality Complaints Management (Effective date 8/23/2024) does not have a timeline fo r initial assessment fo r the market complaints. Your Senior Manager Quality Assu rance 1 c::J stated that initial assessment is generally done within I (b)l, One 1/9/2024, you recorded Complaint# PC-016468 fo r Paiticulate in two vials of~~ (bH4 (tif(4) (bT(4l (b ~(4! mg Vial Lot No 'sI 1(Mfg. date 6/20/2023, Expiiy dateI ·1 and I (Mfg. date 8/14/20 23 , Expiiy date·1 · t"ff1 According to your procedure, criticality ___.... classification fo r pa1t icul at~ matter in dtug product is High/Class 1 that r equii·es to complete the 4 investi,~ation within =:::i You did not complete the Initial Assessment untilL (bH after l (bH 4j of record ing tlie complaint. You did not.

Observation 2 — Responsibilities and procedures fo r quality units are not in writing and/or

Responsibilities and procedures fo r quality units are not in writing and/or fo llowed to ensure a need fo r Biological Product Deviation Report (BPDR) are adequately assessed and reported fo r the distributed products that are implicated with product quality issues. Specifically, The ~ al~.!)' Agreement Betweenl (bY{-4 and Sams ung Bioepis -C 1141 (Effective date C: wi does n ot define the roles ana responsibility fo r dete1mmmg the need fo r filing Biological Product Deviation Repo1t (BPDR). According to the QA, you are responsible fo r handling and investigating all quality related products complaints from the market (Market Complaint) but dete1mining a need fo r submitting BPDR is not defined in the Quality Agreemen t. SEE REVERSE OF THIS PAGE EMPtO YEE(S} SIGNATURE EMPI.O YEE(S) NAME AND TITLE (Print or Type) .. Digitally si gned by RaJIV R. Rajiv R. Sr ivastava -S R Sr i v as t av a , CS O Srivastava -S Da.

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.

Samsung Bioepis Co. Ltd.’s FDA history

Argus HQ has recorded 1 total FDA action tied to Samsung Bioepis Co. Ltd.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What is an FDA Form 483?: A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
Does this Form 483 mean Samsung Bioepis Co. Ltd. violated the law?: No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
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 Samsung Bioepis Co. Ltd. had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Samsung Bioepis Co. Ltd. so far. Argus ingests new FDA records daily.

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

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Full FDA history for Samsung Bioepis Co. Ltd.

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 (2024). November 22, 2024 FDA Form 483 for Samsung Bioepis Co. Ltd. — 2 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-samsung-bioepis-co-ltd-2024-11-22-3010031951

MLA

"November 22, 2024 FDA Form 483 for Samsung Bioepis Co. Ltd. — 2 Citations." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-samsung-bioepis-co-ltd-2024-11-22-3010031951.

Chicago

Argus HQ Research. "November 22, 2024 FDA Form 483 for Samsung Bioepis Co. Ltd. — 2 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-samsung-bioepis-co-ltd-2024-11-22-3010031951.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_samsung_bioepis_co_ltd_2024_11_22_3010031951_2024,
  title = {November 22, 2024 FDA Form 483 for Samsung Bioepis Co. Ltd. — 2 Citations},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-samsung-bioepis-co-ltd-2024-11-22-3010031951},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗