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Form 483

Sitec Labs Limited Form 483, 2015-02-20

FDA issued a Form 483 to Sitec Labs Limited on 2015-02-20 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Sitec Labs Limited · Navi Mumbai, India · Issued February 20, 2015

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.

20 Feb 2015
21 CFR 50.25(a)(2)

Reasonably foreseeable risks or discomforts

Cited by Sandra S Saniga

20 Feb 2015
21 CFR 50.25(a)(5)

Confidentiality, FDA inspection of records

Cited by Sandra S Saniga

Inspected site

SLSitec Labs LimitedNavi Mumbai, India

Inspection team

SSSandra S Saniga

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 50.25(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 50.25(a)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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