Atlas

Form 483

CONCORD BIOTECH LIMITED Form 483, 2017-07-21

FDA issued a Form 483 to CONCORD BIOTECH LIMITED on 2017-07-21 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

CONCORD BIOTECH LIMITED · Ahmedabad, India · Issued July 21, 2017

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

21 Jul 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Steven P Donald

21 Jul 2017
21 CFR 211.84(c)(4)

Compositing of Sub Samples

Cited by Steven P Donald

21 Jul 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Steven P Donald

21 Jul 2017
21 CFR 211.84(c)(4)

Compositing of Sub Samples

Cited by Steven P Donald

Inspected site

CBCONCORD BIOTECH LIMITEDAhmedabad, India

Inspection team

SPSteven P Donald

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.84(c)(4)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

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