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Form 483

Lilly del Caribe, Inc. Form 483, 2011-04-28

FDA issued a Form 483 to Lilly del Caribe, Inc. on 2011-04-28 with 1 public-safe observation.

483· Form 483 issued1 observation

Lilly del Caribe, Inc. · Carolina, United States · Issued April 28, 2011

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

28 Apr 2011
21 CFR 820.100(b)

Documentation

Cited by Rafael Gonzalez, Jason F Chancey

Inspected site

LDLilly del Caribe, Inc.Carolina, United States

Inspection team

RGRafael Gonzalez
JFJason F Chancey

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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  • 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