Atlas

Form 483

Merit Medical Singapore Pte Ltd Form 483, 2016-01-21

FDA issued a Form 483 to Merit Medical Singapore Pte Ltd on 2016-01-21 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Merit Medical Singapore Pte Ltd · Singapore, Singapore · Issued January 21, 2016

Overview

  • 2 public-safe observations are 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.

21 Jan 2016
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Amy M Cramer

21 Jan 2016
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Amy M Cramer

Inspected site

MMMerit Medical Singapore Pte LtdSingapore, Singapore

Inspection team

AMAmy M Cramer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations2x

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