Form 483

Power Organics Inc. Form 483, 2013-07-10

FDA issued a Form 483 to Power Organics Inc. on 2013-07-10 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Power Organics Inc. · Mount Shasta, United States · Issued July 10, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

10 Jul 2013
21 CFR 111.75(a)(2)(ii)(C)

Documentation - qualify supplier

Cited by John A Liu

10 Jul 2013
21 CFR 111.570(b)(2)(ii)(F)

Record - product complaint; findings

Cited by John A Liu

Inspected site

POPower Organics Inc.Mount Shasta, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.570(b)(2)(ii)(F)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(C)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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