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Form 483

Institute for In Vitro Sciences, Inc. Form 483, 2022-06-01

FDA issued a Form 483 to Institute for In Vitro Sciences, Inc. on 2022-06-01 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Institute for In Vitro Sciences, Inc. · Gaithersburg, United States · Issued June 1, 2022

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

1 Jun 2022
21 CFR 58.113(a)(1)

Mixtures: uniformity and concentration

Cited by David L Chon, Ellen A Humphrey

1 Jun 2022
21 CFR 58.63(a)

Equipment: calibration

Cited by David L Chon, Ellen A Humphrey

Inspected site

IFInstitute for In Vitro Sciences, Inc.Gaithersburg, United States

Inspection team

DLDavid L Chon
EAEllen A Humphrey

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 58.113(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 58.63(a)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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The source PDF, 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