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Form 483

Reliance Life Sciences Private Limited Form 483, 2019-02-22

FDA issued a Form 483 to Reliance Life Sciences Private Limited on 2019-02-22 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Reliance Life Sciences Private Limited · Navi Mumbai, India · Issued February 22, 2019

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.

22 Feb 2019
21 CFR 310.305(a)

Failure to develop written procedures

Cited by Tiara N Brown-Crosen

Inspected site

RLReliance Life Sciences Private LimitedNavi Mumbai, India

Inspection team

TNTiara N Brown-Crosen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 310.305(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