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Form 483

Kappa Laboratories, Inc. Form 483, 2022-04-22

FDA issued a Form 483 to Kappa Laboratories, Inc. on 2022-04-22 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Kappa Laboratories, Inc. · Miami, United States · Issued April 22, 2022

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.

22 Apr 2022
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Joanne E King, Kayla V Sprague

Inspected site

KLKappa Laboratories, Inc.Miami, United States

Inspection team

JEJoanne E King
KVKayla V Sprague

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

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  • 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