Atlas

Form 483

K.C. Pharmaceuticals, Inc Form 483, 2012-08-01

FDA issued a Form 483 to K.C. Pharmaceuticals, Inc on 2012-08-01 with 1 public-safe observation.

483· Form 483 issued1 observation

K.C. Pharmaceuticals, Inc · Pomona, United States · Issued August 1, 2012

Overview

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

Inspectional observations

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

1 Aug 2012
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by John A Gonzalez

Inspected site

KPK.C. Pharmaceuticals, IncPomona, United States

Inspection team

JAJohn A Gonzalez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)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.

Book a demoStart a free trial

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