CONCORD BIOTECH LIMITED FDA Inspection Record

FEI 3012520698 ยท Inspections, Form 483s, warning letters and import refusals

CONCORD BIOTECH LIMITED is an FDA-registered facility (FEI 3012520698) located in Ahmedabad, IN. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 17, 2023: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 17, 2023Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Investigations of discrepancies, failures (21 CFR 211.192)
Feb 16, 2018No Action Indicated (NAI)No citations listed

Facility details

Company
CONCORD BIOTECH LIMITED
Location
Ahmedabad (IN)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.