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Articles from Inspection Monitor (April 1, 2008)

1-11 out of 11 article(s)
Title Author Type Words
7-item 483 to device firm for complaints, acceptance/rejection of product: MCT Medical Products, San Antonio, TX, Dallas, TX, District. 477
90% of GMP audit focuses on doc review, interviews, 483 prep, close out. Pickett, Joseph 437
Alternative compliance methods can complement warning letters, seizures, injunctions. Pickett, Joseph 399
ArthoCare Corporation clears FDA audit: ArthoCare Corporation, Sunnyvale, CA, Irvine, CA, District. 205
AvTech Laboratories nets clean audit: AvTech Laboratories, Portage, MI, Detroit, MI, District. 364
Clinical investigator receives 2-item 483 for inadequate case histories: Lee Schwartzberg, M.D., Memphis, TN, New Orleans, LA, District. 887
Inspection log. 187
Quintiles clears GLP audit with no violations: Quintiles, Kansas City, MO, Lenexa, KS, District. 205
Spinal USA slapped with 14-item 483 for faulty design plan review: Spinal USA, Flowood, MS, Nashville, TN, District. 599
Sterilmed passes FDA inspection: Sterilmed, Maple Grove, MN, Minneapolis, MN, District. 255
Yadav cited in 1-item 483 for not adhering to investigational plan: Sanjay Yadav, M.D., Cleveland, OH, Cincinnati, OH, District. 539

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