AM2PAT Documents
Documents, including court filings and FDA inspection records, relating to AM2PAT, the pre-filled syringe distributor charged with shipping tainted syringes that reportedly sickened dozens and killed several people.
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- Consumer Complaint/Injury Report - Mar. 29, 2005
- FDA Establishment Inspection Report, June 5, 2005
- FDA Establishment Inspection Report, Jan. 17, 2006
- Adverse Event Report to FDA, Mar. 19, 2007
- Consumer Complaint/Injury Report to the FDA, June 20, 2007
- FDA Press Release Announcing Syringe Recall, Sept. 14, 2007
- FDA Establishment Inspection Report, Aug. 1, 2007
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FDA Establishment Inspection Report, Dec. 13, 2007
An inspection initiated after the Centers for Disease Control linked AM2PAT syringes to reports of infections.
- Eastern District of North Carolina grand jury indictment naming AM2PAT and Dushyant Patel
- Letters from FDA and AM2PAT to each other
- FDA Warning Letter to AM2PAT, Aug 11, 2005
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