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Form 483

PLEXUS Manufacturing Sdn. Bhd. Form 483, 2014-10-16

FDA issued a Form 483 to PLEXUS Manufacturing Sdn. Bhd. on 2014-10-16 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

PLEXUS Manufacturing Sdn. Bhd. · Bayan Lepas, Malaysia · Issued October 16, 2014

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.

16 Oct 2014
21 CFR 820.184

DHR content

Cited by Stephen C Smith

Inspected site

PMPLEXUS Manufacturing Sdn. Bhd.Bayan Lepas, Malaysia

Inspection team

SCStephen C Smith

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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