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Form 483

Pharmasol Corporation Form 483, 2016-08-04

FDA issued a Form 483 to Pharmasol Corporation on 2016-08-04 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Pharmasol Corporation · South Easton, United States · Issued August 4, 2016

Overview

  • 3 public-safe observations are 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.

4 Aug 2016
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Jonathan G Matrisciano

4 Aug 2016
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Jonathan G Matrisciano

4 Aug 2016
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Jonathan G Matrisciano

Inspected site

PCPharmasol CorporationSouth Easton, United States

Inspection team

JGJonathan G Matrisciano

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations3x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 3 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