Last Update: 05-Mar-13 07:44 ET
Impex Labs shares plunge 20% following FDA inspection of facility
Impax Labs (IPXL $15.98 -4.02) announced that the FDA completed its re-inspection of the Company's Hayward manufacturing facility in connection with the previously disclosed Form 483 issued in March 2012. In addition to the re-inspection, the FDA conducted a Pre-Approval Inspection (PAI) for RYTARYTM, as analytical method validation and a portion of the stability data were generated in Hayward, and a general Good Manufacturing Practices (GMP) inspection. At the conclusion of this inspection, the FDA issued a new Form 483 with twelve (12) observations, three (3) of which are designated as repeat observations from inspections that occurred prior to the Warning Letter. "The Company is working diligently to address the observations raised by the FDA and will respond to these new observations within the fifteen (15) business day period from the receipt of the Form 483." Currently, the Company has not been informed by the FDA of the impact this latest Form 483 will have on the resolution or timing of resolving the warning letter or whether any further regulatory action may be taken as to its manufacturing operations. Until remedial action is complete and the FDA has confirmed compliance with current GMP, approval of pending and new applications listing the Hayward facility as a manufacturing location of finished dosage forms may be withheld.
Impax Labs (IPXL $15.98 -4.02) announced that the FDA completed its re-inspection of the Company's Hayward manufacturing facility in connection with