The GMP Letter

A recent FDA warning letter issued to CooperVision in the wake of a massive contact lens recall is not likely to affect the company’s long-term prospects, analysts say.

Seeing supplier quality issues rise, the FDA is considering issuing agency-wide guidance to clarify manufacturers’ responsibilities on outsourcing, an agency official said last month.

As promised, the FDA last year moved to tighten up loose links in the global device supply chain while addressing criticism that agency decisionmaking is too often opaque.

Durable medical equipment giant Invacare is negotiating a consent decree with the FDA that would temporarily shut some Ohio operations, the company revealed last month.

Precision Systems, a Massachusetts-based maker of osmometers and cryoscopes, received a Form 483 after an inspection of its Natick, Mass., plant found no formal quality policy on hand.

RI Consultants, a maker of radiotherapy devices, was handed a Form 483 for a dearth of device history records and for not identifying the training needs of personnel at its Nashua, N.H., plant.

A recent inspection of Pro-Paks’ Middletown, Conn., plant found a lack of formal documentation for sterilization validation and re-validation processes for production of Lasik surgical kits.

Poor corrective and preventative action (CAPA) procedures and lack of adverse event reporting garnered a warning letter for Beckman Coulter’s Miami-based cellular analysis business.

The FDA has warned Midmark after the devicemaker failed to strengthen corrective and preventive action (CAPA) procedures at its Versailles, Ohio, facility as the agency urged in an earlier Form 483.

An FDA working group on guidance development says the agency should encourage devicemakers to submit draft guidance rather than just guidance topics to help the agency understand the issues and expedite guidance development.