Key facts
| Firm | Concord Biotech Limited |
|---|---|
| FEI / inspection ID | 3004126703 |
| Inspection end date | May 2, 2025 |
| Citation count | 2 |
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.
Citations explained
Observation 1 — Failure to clean equipment and utensils to prevent contamination or carry-over of
Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the intermediates and AP! beyond the official or other established specifications. Specifically, During my walkthrough inspectionF21f our rr1an.u(ag!l.rin!L.E.L�nr ,., J ]I''observed esidues on the • (b)(4j (b)(4). � )(4 . agitator and around the walls of aL.- _________, 1. I also observedi ___partJcles on the bottom of thd (b,Accord1ng to the logbook your firm performed after use cleaning on 1 (b)(4� (b)(4) • - (b)-ro . r(b� . . . 1 (b)(41;, . nd Jcleanmg on jTh1s Juttlized in the • perat1on of ::}ctive Pharmaceutical Ingredient.
Observation 2 — Laboratory controls do not include the establishment of scientifically sound and appropriate
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity. Specifically, SEE REVERSE OF THIS PAGE
Concord Biotech Limited’s FDA history
Argus HQ has recorded 1 total FDA action tied to Concord Biotech Limited: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Does this Form 483 mean Concord Biotech Limited 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 Concord Biotech Limited had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Concord Biotech Limited so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3004126703.
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Related enforcement actions
Full FDA history for Concord Biotech LimitedCompiled 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.
Argus HQ Research (2025). Form 483 Record: Concord Biotech Limited, May 2, 2025 — 2 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-concord-biotech-limited-2025-05-02-3004126703
"Form 483 Record: Concord Biotech Limited, May 2, 2025 — 2 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-concord-biotech-limited-2025-05-02-3004126703.
Argus HQ Research. "Form 483 Record: Concord Biotech Limited, May 2, 2025 — 2 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-concord-biotech-limited-2025-05-02-3004126703.
@misc{argushq_argushq_ai_483_fda_483_concord_biotech_limited_2025_05_02_3004126703_2025,
title = {Form 483 Record: Concord Biotech Limited, May 2, 2025 — 2 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-concord-biotech-limited-2025-05-02-3004126703},
note = {Accessed: July 15, 2026}
}