FDA issues warning letter to Abbott Diabetes Care manufacturing plant
ROCKVILLE, Md. The Food and Drug Administration earlier this week posted a July 2 warning letter addressing quality concerns at an Abbott Diabetes Care manufacturing plant.
The warning letter outlined some of the specific violations of good manufacturing practices for the manufacturer of the FreeStyle blood glucose meter, including not following through on reports concerning empty blister packs being produced on the Noack Blister Packer at one of Abbott’s establishments. Similarly, an exception report initiated on April 8, 2008, for scratches on FreeStyle Lite strips was closed with no corrective action or effectiveness check, the agency stated.
Abbott is working with the FDA to address the agency’s concerns.
Vitamin Shoppe reports 12.3% sales jump in Q2
NORTH BERGEN, N.J. Vitamin Shoppe on Thursday posted a 12.3% lift in sales for its second quarter ended June 26. Sales reached $192.2 million.
“2010 started strong and that momentum continued into the second quarter,” stated Rick Markee, Vitamin Shoppe chairman and CEO. “Comparable-store sales for the second quarter of 2010 increased 8.6%, making this our 19th consecutive quarter of comparable same-store sales growth,” he said.
Much of that same-store sales performance can be attributed to the maturing of the retailer’s store base, Markee told analysts Thursday morning. Approximately 40% of the Vitamin Shoppe store base is less than four years old, he said. However, mature stores are experiencing positive comps as well, he added.
The company operated 463 stores as of June 26, compared with 425 stores in the same quarter last year.
In an update on its 2010 outlook, Vitamin Shoppe expected to now spend approximately $22 million in total capital expenditures, which should bring the new store count for the year to 46 from 42.
The company expected comparable-store sales growth for the remainder of the year in line with industry growth in the mid-single digits.
Report: J&J’s Lancaster, Pa., plant under fire
NEW YORK A third Johnson & Johnson manufacturing facility has come under Food and Drug Administration scrutiny following an inspection, according to published reports.
J&J confirmed it had received a Form 483 from the FDA regarding its Lancaster, Pa., plant, which is a joint venture between J&J and Merck Consumer Pharmaceuticals that manufacturers the heartburn remedy Pepcid.
J&J also revealed the company had received a grand jury subpoena from the U.S. Attorney’s Office in Philadelphia during its conference call on Tuesday, though declined to provide more information on that matter.