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Form 483

Aurolab Trust DBA Aurolab Form 483, 2020-02-06

FDA issued a Form 483 to Aurolab Trust DBA Aurolab on 2020-02-06 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Aurolab Trust DBA Aurolab · Veerapanjan Madurai, India · Issued February 6, 2020

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.

6 Feb 2020
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Seema S Singh

Inspected site

ATAurolab Trust DBA AurolabVeerapanjan Madurai, India

Inspection team

SSSeema S Singh

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

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  • 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