Just Issued Recalls, 483s, Laws, & Warning Letters | October 2018

Enforcement:

• Recalls:
  • A handful of both classified and unclassified
    • Among the unclassified recalls are additional recalls of Valsartan-like APIs. Seems like this will be going on for a while!
  • Class II and III recalls
• Import Alerts:
  • Several import alerts for preventing FDA inspections

• Warning Letters:
  • Drug Manufacturers: 2 warning letters including 1 issued to a PET drug manufacturer
  • Clinical Trial Investigator: 1 warning letter
  • Compounding Pharmacies: 3 warning letters
  • GCP: 1 warning letter
  • Device Firms: 2 warning letters plus 4 letters to device manufacturers located outside the US
• 483s:
  • Numerous 483s issued to compounding firms
  • 1 483 from a recent inspection of Cipla Limited
• Consent Decree Agreement: 1 firm
• The Europeans Published:
  • 2 reports of GDP non-compliance including 1 to a distribution center
  • A few reports of GMP non-compliance including 1 issued to a firm in the UK

Laws & Guidance:

• Guidance | The HPRA, EMA, Health Canada, CDSCO, TGA, and WHO all published guidance including:
  • 17 from the FDA with:
    • 3 focusing on generic drugs
    • 2 addressing requirements for transdermal patches
  • EMA published:
    • Revisions to a Q&A
    • 2 guidance addressing implementation of the new MDR regulations in 2020
• The EMA, MHRA, TGA, HPRA, CDSCO, and FDA all published non-guidance.