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Form 483

Modavar Pharmaceuticals Form 483, 2023-01-27

FDA issued a Form 483 to Modavar Pharmaceuticals on 2023-01-27 with 8 public-safe observations.

483· Form 483 issuedHuman Drugs8 observations

Modavar Pharmaceuticals · Frederick, United States · Issued January 27, 2023

Overview

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

Inspectional observations

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

27 Jan 2023
21 CFR 211.111

Establishment of time limitations

Cited by Kathleen M Jordan, Jazmine N Brown, Amy N Chen

27 Jan 2023
21 CFR 211.160(b)(2)

In-process sample representation/identification

Cited by Kathleen M Jordan, Jazmine N Brown, Amy N Chen

27 Jan 2023
21 CFR 211.166(a)(1)

Sample size - test intervals

Cited by Kathleen M Jordan, Jazmine N Brown, Amy N Chen

27 Jan 2023
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Kathleen M Jordan, Jazmine N Brown, Amy N Chen

27 Jan 2023
21 CFR 211.63

Equipment Design, Size and Location

Cited by Kathleen M Jordan, Jazmine N Brown, Amy N Chen

Inspected site

MPModavar PharmaceuticalsFrederick, United States

Inspection team

KMKathleen M Jordan
JNJazmine N Brown
ANAmy N Chen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.68(b)Cited across public-safe Form 483 observations2x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 8 observations

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