Atlas

Form 483

Becton Dickinson Caribe LTD Form 483, 2012-03-13

FDA issued a Form 483 to Becton Dickinson Caribe LTD on 2012-03-13 with 2 public-safe observations.

483· Form 483 issued2 observations

Becton Dickinson Caribe LTD · Cayey, United States · Issued March 13, 2012

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

13 Mar 2012
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Marilyn Santiago

13 Mar 2012
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Marilyn Santiago

Inspected site

BDBecton Dickinson Caribe LTDCayey, United States

Inspection team

MSMarilyn Santiago

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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