FDA Webview
EIRS/483s
Federal Register notice: FDA classifies prognostic tests for assessing liver-related disease progres...
EIRS/483s
Hyman Phelps & McNamara attorneys Mark Tobolowsky and Charles Raver say a recent legislative change ...
EIRS/483s
FDA commissioner Robert Califf calls for better evidence generation and suggests that with the rapid...
EIRS/483s
Lawyers from Troutman Pepper say that two recent medical product cases could be a harbinger of more ...
EIRS/483s
FDA approves an IntelGenx 505(b)(2) NDA for RizaFilm VersaFilm (rizatriptan benzoate) for treating a...
EIRS/483s
Industry news you may have missed since our last issue.
EIRS/483s
FDA-483 issued 10/23/97
EIRS/483s
Company response dated 7/14/98
EIRS/483s
Warning Letter dated 6/25/98
EIRS/483s
Lyons, IL facility inspected 11/16-22/99; FDA Form 483; Warning Letter 1/5/00 and company response
EIRS/483s
Wilmington, CA facility inspected 1/10,13-14/00; FDA Form 483
EIRS/483s
Teachey, NC facility inspected 4/12-4/15/99; FDA 48 4/15/99, Warning Letter 8/2/99
EIRS/483s
Haw River, NC facility inspected 4/19-29/99; FDA 483, Warning Letter 6/28/99
EIRS/483s
FDA-483 issued 3/98 to Buena, NJ facility
EIRS/483s
FDA-483 issued 10/98 to Buena, NJ facility
EIRS/483s
FDA-483 issued 4/98 to Buena, NJ facility
EIRS/483s
Company response dated 4/14/98 to 2-3/98 inspection
EIRS/483s
Company response dated 5/22/98 to FDA Warning Letter
EIRS/483s
Company response dated 5/4/98 to 3-4/98 inspection at Buena, NJ facility
EIRS/483s
Burr Ridge, IL facility inspected 1/19-28/99; FDA Form 483.
