Form 483

Rho, Inc. Form 483, 2017-06-30

FDA issued a Form 483 to Rho, Inc. on 2017-06-30 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Rho, Inc. · Chapel Hill, United States · Issued June 30, 2017

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

30 Jun 2017
21 CFR 312.50

Ensuring compliance with plan and protocol

Cited by Michael Serrano, Jean M Mulinde

Inspected site

RIRho, Inc.Chapel Hill, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 1 observation

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