Atlas

Form 483

Continental Manufacturing Chemist, Inc. Form 483, 2017-04-28

FDA issued a Form 483 to Continental Manufacturing Chemist, Inc. on 2017-04-28 with 52 public-safe observations.

483· Form 483 issuedHuman Drugs52 observations

Continental Manufacturing Chemist, Inc. · Madrid, United States · Issued April 28, 2017

Overview

  • 52 public-safe observations are available for this inspection.
  • 12 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.

28 Apr 2017
21 CFR 111.123(a)(8)

Quality control - finished batch, distribution

Cited by Brett R Havranek

28 Apr 2017
21 CFR 111.123(a)(8)

Quality control - finished batch, distribution

Cited by Brett R Havranek

28 Apr 2017
21 CFR 111.123(a)(8)

Quality control - finished batch, distribution

Cited by Brett R Havranek

28 Apr 2017
21 CFR 111.123(a)(8)

Quality control - finished batch, distribution

Cited by Brett R Havranek

28 Apr 2017
21 CFR 111.205(a)

Master manufacturing record - unique formulation

Cited by Brett R Havranek

Inspected site

CMContinental Manufacturing Chemist, Inc.Madrid, United States

Inspection team

BRBrett R Havranek

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations8x
21 CFR 111.123(a)(8)Cited across public-safe Form 483 observations4x
21 CFR 111.205(a)Cited across public-safe Form 483 observations4x
21 CFR 111.70(b)(1)Cited across public-safe Form 483 observations4x
21 CFR 211.142(a)Cited across public-safe Form 483 observations4x
21 CFR 211.160(a)Cited across public-safe Form 483 observations4x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations4x
21 CFR 211.188(b)(8)Cited across public-safe Form 483 observations4x
21 CFR 211.194(a)Cited across public-safe Form 483 observations4x
21 CFR 211.198(a)Cited across public-safe Form 483 observations4x
21 CFR 211.22(d)Cited across public-safe Form 483 observations4x
21 CFR 211.68(b)Cited across public-safe Form 483 observations4x

Full 483 report

Get the verbatim text of all 52 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