Atlas

Form 483

Brisas Del Caribe Corp Form 483, 2016-02-04

FDA issued a Form 483 to Brisas Del Caribe Corp on 2016-02-04 with 10 public-safe observations.

483· Form 483 issuedHuman Drugs10 observations

Brisas Del Caribe Corp · Canovanas, United States · Issued February 4, 2016

Overview

  • 10 public-safe observations are available for this inspection.
  • 5 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.

4 Feb 2016
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Libia M Lugo

4 Feb 2016
21 CFR 211.165(a)

Testing and release for distribution

Cited by Libia M Lugo

4 Feb 2016
21 CFR 211.166(a)

Written program not followed

Cited by Libia M Lugo

4 Feb 2016
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Libia M Lugo

4 Feb 2016
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Libia M Lugo

Inspected site

BDBrisas Del Caribe CorpCanovanas, United States

Inspection team

LMLibia M Lugo

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(a)Cited across public-safe Form 483 observations2x
21 CFR 211.165(a)Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)Cited across public-safe Form 483 observations2x
21 CFR 211.188Cited across public-safe Form 483 observations2x
21 CFR 211.68(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 10 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