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Form 483

Contract Pharmacal Corp. Form 483, 2012-01-25

FDA issued a Form 483 to Contract Pharmacal Corp. on 2012-01-25 with 3 public-safe observations.

483· Form 483 issued3 observations

Contract Pharmacal Corp. · Hauppauge, United States · Issued January 25, 2012

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

25 Jan 2012
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Alice S Tsao

25 Jan 2012
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Alice S Tsao

25 Jan 2012
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Alice S Tsao

Inspected site

CPContract Pharmacal Corp.Hauppauge, United States

Inspection team

ASAlice S Tsao

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)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.

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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