Atlas

Form 483

Pharmasol Corporation Form 483, 2013-10-30

FDA issued a Form 483 to Pharmasol Corporation on 2013-10-30 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Pharmasol Corporation · South Easton, United States · Issued October 30, 2013

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

30 Oct 2013
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Justine M Corson

30 Oct 2013
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Justine M Corson

30 Oct 2013
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Justine M Corson

30 Oct 2013
21 CFR 211.180(e)

Records reviewed annually

Cited by Justine M Corson

30 Oct 2013
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Justine M Corson

Inspected site

PCPharmasol CorporationSouth Easton, United States

Inspection team

JMJustine M Corson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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