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Form 483

CONCORD BIOTECH LIMITED Form 483, 2018-10-18

FDA issued a Form 483 to CONCORD BIOTECH LIMITED on 2018-10-18 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

CONCORD BIOTECH LIMITED · Ahmedabad, India · Issued October 18, 2018

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

18 Oct 2018
21 CFR 211.160(a)

Deviations from laboratory control requirements

Cited by Alan P Kurtzberg

Inspected site

CBCONCORD BIOTECH LIMITEDAhmedabad, India

Inspection team

APAlan P Kurtzberg

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere