Atlas

Form 483

Coral Drugs Private Limited Form 483, 2018-02-23

FDA issued a Form 483 to Coral Drugs Private Limited on 2018-02-23 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Coral Drugs Private Limited · Rai, India · Issued February 23, 2018

Overview

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

Inspectional observations

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

23 Feb 2018
21 CFR 211.22(a)

Authority lacking to review records, investigate errors

Cited by Jai P Singh, Valerie L Whipp

23 Feb 2018
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Jai P Singh, Valerie L Whipp

23 Feb 2018
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Jai P Singh, Valerie L Whipp

23 Feb 2018
21 CFR 211.80(a)

Written Procedures Not Followed

Cited by Jai P Singh, Valerie L Whipp

Inspected site

CDCoral Drugs Private LimitedRai, India

Inspection team

JPJai P Singh
VLValerie L Whipp

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

Every observation in full, 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