GMP consultants working for Caraco have put the finishing touches on a work plan that will let the drugmaker resume manufacturing at its Michigan facilities. The company now awaits FDA approval of the plan, in accordance with its consent decree.
Caraco maintains in its third quarter earnings report that it will pursue the release of some of the inventory seized by U.S. Marshals last June, as reported earlier [1]. Raw materials worth some $8.1 million were opened "solely for the purpose of sampling," during the seizure, says Caraco. The remainder "would be difficult to recondition," the company tells its investors. The company created a $15.9 million reserve last December for this remaining inventory.
Based on its rehab progress to date, Caraco has started recalling some of the 430 employees it let go when manufacturing was halted. The returning employees, it says, are working on manufacturing-restart effort.
- see the Caraco announcement [2]
Related Articles:
Caraco - Top 12 GMP Violations [3]
Deviations attract investor lawyers [4]
GMP deviators keep paying [5]
R&D accepts new assignment [6]
FDA seizure intended to drive "major changes" at Caraco [7]
Links:
[1] http://www.fiercepharmamanufacturing.com/story/caraco-its-all-gmp-now/2009-09-29
[2] http://www.fiercebiotech.com/press-releases/caraco-pharmaceutical-laboratories-ltd-reports-results-third-quarter-and-first-nine-0
[3] http://www.fiercepharmamanufacturing.com/special-reports/caraco-top-12-gmp-violations
[4] http://www.fiercepharmamanufacturing.com/story/deviations-attract-investor-lawyers/2009-11-10
[5] http://www.fiercepharmamanufacturing.com/story/gmp-deviators-keep-paying/2009-11-04
[6] http://www.fiercepharmamanufacturing.com/story/r-d-accepts-new-assignment/2009-10-28
[7] http://www.fiercepharmamanufacturing.com/story/fda-seizure-intended-drive-major-changes-caraco/2009-06-29