The FDA has warned Cordis, a subsidiary of Johnson & Johnson, that its plant in San German, Puerto Rico, failed to ensure that its stents were properly made.
The letter, dated Feb. 16, said the inspection found that the devices were adulterated within the meaning of section 501 of the Federal Food, Drug and Cosmetic Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage or installation are not in conformity with the current good manufacturing practice (cGMP) requirements of the quality system regulation.
The violations include, but are not limited to:
- A corrective and preventive action (CAPA) plan that failed to correct and prevent nonconforming products.
- Process control procedures that failed to ensure that a device conforms to its specifications.
With regards to the CAPA, the letter said that approximately eight months after the opening of CAPA during the release compliance test for the stent expansion conformance for your Cypher U.S. lot, an operator reported that a stent tested did not completely conform to the compliance test. The test was conducted obtaining failure results on 15 of 15 units tested, and the stent diameter was not adequate.
With regards to the second violation, the FDA said its expectation is that devices comply with their predetermined specifications and design output at the time of release/use and not relying on the end users to address nonconforming products. “In addition, a critical device such as implantable stents must comply with their predetermined specification at the time of use to avoid complications with the surgical procedures and reduce patient risk,” the letter stated.