About FDA
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Caraco Pharmaceutical Laboratories
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Caraco Pharmaceutical Laboratories. Complaint DET-DO FOI 2009-5622 (PDF - 304KB)Caraco Pharmaceutical Laboratories.First Amended Complaint DET-DO FOI 2009-5622 (PDF - 304KB)Caraco Pharmaceutical Laboratories. Consent Decree (PDF - 1.4MB)Caraco Pharmaceutical Laboratories. Farmington Hills, MI. Response Letter to Form 483 issued 12/22/2008 (PDF - 327KB)Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI. Response letter to 483 issued 5/12/2009 (PDF - 2.7MB)Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI 483 issued 5/12/2009 (14 pages) (PDF - 659KB)Caraco Pharmaceutical Laboratories, Inc., 483 Inspectional Observations, Detroit, MI, inspection 05/01/2008 - 06/11/2008, and Related Correspondence from Firm Caraco Pharmaceutical Laboratories. Wixom, MI. Establishment Inspection Report (EIR) cover sheet. 04/09/2009 (PDF - 270KB)Caraco Pharmaceutical Laboratories. Farmington Hills, MI. Establishment Inspection Report (EIR). 12/11/2008 – 12/22/2008 (PDF - 531KB)Caraco Pharmaceutical Laboratories. Farmington Hills, MI. Form 483 (Inspectional Observations). 12/11/2008 - 12/22/2008 (PDF - 71KB)Caraco Pharmaceutical Laboratories. Recall Enterprise System (RES)Digoxin Recall Details (PDF - 202KB)
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