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Form 483

Pharmasol Corporation Form 483, 2015-07-16

FDA issued a Form 483 to Pharmasol Corporation on 2015-07-16 with 36 public-safe observations.

483· Form 483 issuedHuman Drugs36 observations

Pharmasol Corporation · South Easton, United States · Issued July 16, 2015

Overview

  • 36 public-safe observations are available for this inspection.
  • 12 structured CFR citations are represented.
  • 5 investigators are tied to this Form 483.

Inspectional observations

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

16 Jul 2015
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Uttaniti Limchumroon, William J Leonard, Cassandra L Abellard, Kim L Thomas Cruse, Yvonne Y Wu

16 Jul 2015
21 CFR 211.111

Establishment of time limitations

Cited by Uttaniti Limchumroon, William J Leonard, Cassandra L Abellard, Kim L Thomas Cruse, Yvonne Y Wu

16 Jul 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Uttaniti Limchumroon, William J Leonard, Cassandra L Abellard, Kim L Thomas Cruse, Yvonne Y Wu

16 Jul 2015
21 CFR 211.165(e)

Test methods

Cited by Uttaniti Limchumroon, William J Leonard, Cassandra L Abellard, Kim L Thomas Cruse, Yvonne Y Wu

16 Jul 2015
21 CFR 211.182

Written records kept in individual logs

Cited by Uttaniti Limchumroon, William J Leonard, Cassandra L Abellard, Kim L Thomas Cruse, Yvonne Y Wu

Inspected site

PCPharmasol CorporationSouth Easton, United States

Inspection team

ULUttaniti Limchumroon
WJWilliam J Leonard
CLCassandra L Abellard
KLKim L Thomas Cruse
YYYvonne Y Wu

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations3x
21 CFR 211.111Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations3x
21 CFR 211.165(e)Cited across public-safe Form 483 observations3x
21 CFR 211.182Cited across public-safe Form 483 observations3x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.194(a)Cited across public-safe Form 483 observations3x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations3x
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 211.25(a)Cited across public-safe Form 483 observations3x
21 CFR 211.68(a)Cited across public-safe Form 483 observations3x
21 CFR 211.68(b)Cited across public-safe Form 483 observations3x

Source document

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PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 36 observations

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