Atlas

Form 483

Ipca Laboratories Limited Form 483, 2017-03-08

FDA issued a Form 483 to Ipca Laboratories Limited on 2017-03-08 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Ipca Laboratories Limited · Mumbai, India · Issued March 8, 2017

Overview

  • 2 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.

8 Mar 2017
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Ivy E Sweeney

8 Mar 2017
21 CFR 314.81(b)(2)

Timely submission

Cited by Ivy E Sweeney

Inspected site

ILIpca Laboratories LimitedMumbai, India

Inspection team

IEIvy E Sweeney

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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