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Form 483

Theranos, Inc. Form 483, 2015-09-16

FDA issued a Form 483 to Theranos, Inc. on 2015-09-16 with 5 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health5 observations

Theranos, Inc. · Palo Alto, United States · Issued September 16, 2015

Overview

  • 5 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.

16 Sep 2015
21 CFR 820.30(c)

Design input - documentation

Cited by Seema S Singh

16 Sep 2015
21 CFR 820.30(g)

Design validation - Risk analysis

Cited by Seema S Singh

16 Sep 2015
21 CFR 820.30(g)

Design validation - simulated testing

Cited by Seema S Singh

16 Sep 2015
21 CFR 820.30(g)

Design validation - user needs and intended uses

Cited by Seema S Singh

16 Sep 2015
21 CFR 820.40(a)

Document review, approval by designated individual

Cited by Seema S Singh

Inspected site

TITheranos, Inc.Palo Alto, United States

Inspection team

SSSeema S Singh

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations3x
21 CFR 820.30(c)Cited across public-safe Form 483 observations1x
21 CFR 820.40(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 5 observations

The source PDF and 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