Atlas

Form 483

Ajanta Pharma USA Inc Form 483, 2016-03-17

FDA issued a Form 483 to Ajanta Pharma USA Inc on 2016-03-17 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Ajanta Pharma USA Inc · Bridgewater, United States · Issued March 17, 2016

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.

17 Mar 2016
21 CFR 314.80(c)(2)

Interval

Cited by Michael Serrano

17 Mar 2016
21 CFR 314.80(c)(2)

Late submission of quarterly safety reports

Cited by Michael Serrano

17 Mar 2016
21 CFR 314.81(b)(2)

Timely submission

Cited by Michael Serrano

17 Mar 2016
21 CFR 314.80(c)(2)

Late submission of quarterly safety repo

Cited by Michael Serrano

Inspected site

APAjanta Pharma USA IncBridgewater, United States

Inspection team

MSMichael Serrano

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(c)(2)Cited across public-safe Form 483 observations3x
21 CFR 314.81(b)(2)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