Concord Biotech Limited FDA Record

Summary

FDA record by year

Concord Biotech Limited's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Concord Biotech Limited Form 483s

1 Form 483 published by FDA.

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

8 inspections from Aug 10, 2012 to May 2, 2025.

NAI

No objectionable conditions or practices were found during the inspection.

VAI

Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

OAI

Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

3 inspected sites, newest inspection first.

Concord Biotech Limited and the FDA: common questions

Has Concord Biotech Limited received an FDA warning letter?

No FDA warning letter addressed to the name "Concord Biotech Limited" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Concord Biotech Limited received an FDA Form 483?

FDA has published 1 Form 483 for Concord Biotech Limited in its reading room, the most recent dated May 2, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Concord Biotech Limited?

The most recent FDA inspection on file ended May 2, 2025 at Ahmedabad, Gujarat State, India and was classified VAI. FDA has 8 inspections of Concord Biotech Limited on file.