Form 483

Hyland's Consumer Health Inc. Form 483, 2009-06-22

FDA issued a Form 483 to Hyland's Consumer Health Inc. on 2009-06-22 with 4 public-safe observations.

483· Form 483 issued4 observations

Hyland's Consumer Health Inc. · Los Angeles, United States · Issued June 22, 2009

Overview

  • 4 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.

22 Jun 2009
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Linda Thai

22 Jun 2009
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Linda Thai

22 Jun 2009
21 CFR 314.80(b)

Failure to review ADE information

Cited by Linda Thai

22 Jun 2009
21 CFR 314.81(b)(2)

Timely submission

Cited by Linda Thai

Inspected site

HCHyland's Consumer Health Inc.Los Angeles, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(b)Cited across public-safe Form 483 observations2x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

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