Medical Device Daily Washington Editor
FDA's Dec. 20 posting of the warning letter to CooperVision (Pleasanton, California) cited the firm's operation of a packing plant in West Henrietta, New York, but the warning letter gave no indication of the cause of a recall reported earlier this year for the firm's Avaira Toric contact lens (Medical Device Daily, Oct. 17, 2011). The Dec. 5 warning letter cited the firm for various problems with packing procedures, but the impact of the recall of the Avaira Toric contact lens, the warning letter, and allegations of securities fraud by the firm's parent company seems to have done the firm's shares little discernible damage.
The Cooper Companies (Pleasanton, California), CooperVision's parent firm, was named as the target of a class action securities fraud lawsuit in a Nov. 30 statement by Gilman Law (Bonita Springs, Florida), which alleges that Cooper “issued false and misleading statements that caused the Company's stock to trade at artificially inflated prices.“ The statement pegs this allegation to a purported failure to disclose that CooperVision's manufacturing plants in Puerto Rico and the UK “were experiencing serious manufacturing process defects and quality control problems, resulting in dangerously high levels of silicone oil residue being left on the contact lenses.“ The suit also alleges that Cooper “intentionally downplayed the extent of the quality control problems and the breadth of products involved in the August 2011 recall announcement,“ and that the problems led to Cooper's failure “to meet the fiscal 2011 and 4Q 2011 financial guidance.“
Cooper's position in a Dec. 8 statement flatly disagrees with the allegations made by Gilman Law. The company said that FDA issued no form 483s for inspections of the plant in Puerto Rico and an unspecified location in New York, adding that the agency intends to inspect the company's plant in the UK as well, although the date was not known. The statement also notes that the 483 for the West Henrietta inspection included five observations “related to labeling and packaging, and are not product specific.“ The company notes that Cooper and CooperVision are “working closely with the FDA to resolve these observations.“
In an unattributed statement e-mailed to Medical Device Daily, CooperVision reiterated that it is “working with the FDA to resolve its concerns regarding the packaging and labeling matters at the distribution facility in West Henrietta, NY,“ and that the “concerns were not product specific.“ The statement adds that the inspections of the plants in Puerto Rico and Scottsville, New York, resulted in no observations, and concluded, “the health and safety of our customers is our highest priority.“
A Dec. 20 flash comment by Wells Fargo (New York) says that the warning letter for the West Henrietta plant “seems to be a relative[ly] standard one . . . and does not appear to convey an especially high level of concern by the agency.“ The comment indicates that Wells sees the warning letter as “a small negative but unlikely to materially affect results.“ The note indicates a belief that the firm will be able to re-launch the Avaira Toric in April 2012 via another 510(k) filing “even if the warning letter is not resolved by that time.“ Wells anticipates an earnings-per-share of $4.92 for fiscal 2012. The firm's Dec. 8 statement notes that Cooper's fourth quarter FY 2011 revenue “increased 15% year-over-year to $360.9 million“ and that fiscal 2011 revenue also increased 15%, rising to roughly $1.3 billion.
The warning letter includes five citations, the same number Cooper said appeared in the 483, most of which had to do with quality control of labels appearing on cartons and the contents of the cartons. In a validation finding under 21 CFR 820, FDA says that the company failed to “open up the cartons to ensure“ that labels on the blister packs inside matched the labels on the carton during performance qualification of packaging equipment. The warning letter says that CooperVision did not “define the number of runs or the number of units per run“ to be conducted during qualification.
A second point brought up under this citation was that CooperVision was cleaning the sensors used to read bar codes on the un-labeled blister packs “once every 15 weeks“ despite procedures calling for weekly cleaning. FDA says the firm “did not perform any testing“ to see whether the change in cleaning schedule created any problems.
FDA also cited several instances of mismatched containers and products under a citation each for corrective and preventive action (CAPA) and for complaint handling (C-H). The complaint handling citation says that the company failed to conduct a root cause analysis in connection with six complaints, although none of the incidents cited under CAPA or C-H were said to have involved the recalled Avaira Toric lens.
The second citation in the warning says that CooperVision lacked a procedure for “finished device acceptance for labeling operations for any of [the firm's] products.“ The warning letter also says that the company had not established and maintained procedures for device history records to ensure devices were manufactured appropriately, adding that the company's response did not indicate what steps the firm would take to avert any adulteration while a permanent fix is deployed.
The warning letter says that the adequacy of the firm's Nov. 3 response to the inspection could not be assessed as of the date of the warning principally because the firm's corrective actions are, for the most part, not scheduled for completion until early next year.
CMS announces at-home demo
Those in the telemedicine business have a bit more to cheer about with the announcement last week that the Centers for Medicare & Medicaid Services commenced with a demonstration program as of Dec. 21 for chronically ill Medicare beneficiaries for cost-saving coordinated care. According to the Dec. 21 edition of the Federal Register, the idea behind the pilot program is “to test a payment incentive and service delivery system that utilizes physician and nurse practitioner directed, home-based primary care teams aimed at improving health outcomes.“
The FR notice states that participants must provide services to an average of at least 200 beneficiaries to qualify during the first year and “not drop below that average for the remainder of the [three-year] demonstration.“ Providers “must use electronic health information systems, remote monitoring, and mobile diagnostic technology“ to participate, and must be available to patients 24/7 as well. Providers can participate as sole legal entities, as part of a consortium, or as part of “a national pool,“ the FR notice states, although CMS goes into no detail as to what characterizes a consortium or national pool.