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Form 483

SomnoMed Phillipines Inc. Form 483, 2016-01-28

FDA issued a Form 483 to SomnoMed Phillipines Inc. on 2016-01-28 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

SomnoMed Phillipines Inc. · Makati City, Philippines · Issued January 28, 2016

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

28 Jan 2016
21 CFR 820.20(c)

Management review - defined interval, sufficient frequency

Cited by Evelyn Taha

28 Jan 2016
21 CFR 820.40(a)

Document review procedures, designated individual

Cited by Evelyn Taha

28 Jan 2016
21 CFR 820.86

Acceptance status

Cited by Evelyn Taha

Inspected site

SPSomnoMed Phillipines Inc.Makati City, Philippines

Inspection team

ETEvelyn Taha

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.40(a)Cited across public-safe Form 483 observations1x
21 CFR 820.86Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

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