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  FDA Warning Letter/
Notice of Violation Letter		  


Recently Issued FDA Warning Letters/
Notice of Violation Letters
 

Link:  Pharm/Biotech Resources
 

  1. The Medicines Company (Angiomax (bivalirudin) for Injection)
     
  2. UNAM, Facultad De Estudios Superiores Cuautitlan (Manufacture of APIs)
     
  3. Farma Quimia S.A. de C.V. (Manufacture of APIs)
     
  4. Ferring Pharmaceuticals, Inc. (Firmagon (degarelix for injection) for subcutaneous administration)
     
  5. Pax-All Manufacturing, Inc. (Significant Violations of Current Good Manufacturing Practice)
     
  6. Biogen Idec (Avonex (Interferon beta-1a) IM Injection)
     
  7. Laboratorios Jaloma S.A. de C.V. (Significant Violations of Current Good Manufacturing Practice (CGMP))
     
  8. Teva Pharmaceuticals USA (Copaxone (glatiramer acetate injection) solution for subcutaneous injectioon)
     
  9. Nobilus Ent (Manufacture of APIs)
     
  10. Wintac Limited (Regulations for finished pharmaceuticals)
     
  11. Gulf Pharmaceutical Industries (Significant violations of Current Good Manufacturing Practice (CGMP))
     
  12. Dow Pharmaceutical Sciences, Inc. (Atralin (tretinoin) gel, 0.05%)
     
  13. Merck Sharp and Dohme Corp. (Postmarket Requirements (PMRs))
     
  14. Labor L+S AG (Manufacture of Finished Pharmaceuticals)
     
  15. Novartis Oncology (Gleevec (imatinib mesylate) tablets for oral use)
     
  16. Celgene Corporation (Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound))
     
  17. Dr. Reddy's Laboratories, Inc. (Fondaparinux Sodium Solution for subcutaneous injection)
     
  18. Mutual Pharmaceutical Company, Inc. (Colcrys (colchicine, USP) tablets for Oral use)
     
  19. Sunovion Pharmaceuticals, Inc. (Latuda (lurasidone HCl) Tablets)
     
  20. NeurogesX, Inc. (Qutenza (capsaicin) 8% patch)

    

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