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Regulatory Actions

What actions is the FDA taking regarding computer systems? Each month we update this section with Warning Letters, 483s, and summaries of enforcement actions taken by the FDA related to computer systems and software. Learn what FDA compliance really means.

Resources:
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3M Pharmaceuticals, 9/99
  • 483s
  • Regulatory Actions
A & L Laboratories, 6/00
  • Warning Letters
  • Regulatory Actions
A-Vox Systems, 4/02
  • Warning Letters
  • Regulatory Actions
Abbott Health Products, 12/99
  • 483s
  • Regulatory Actions
Abbott Laboratories, 1/02
  • 483s
  • Regulatory Actions
Abbott Laboratories, 10/02
  • Warning Letters
  • Regulatory Actions
Able Laboratories, 7/05
  • 483s
  • Regulatory Actions
AccuMed, 6/98
  • Warning Letters
  • Regulatory Actions
Actavis Totowa, 2/07
  • Warning Letters
  • Regulatory Actions
Advanced Sterilization Products, 12/04
  • Warning Letters
  • Regulatory Actions
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