American Medical Systems was handed an FDA warning letter for failure to conduct an investigation and other quality slips.
A postmarket surveillance report for the AMS 800 Urinary Control System included an action item for further investigation to find the root cause of a potential rise in complaints related to atrophy and cuff malposition/migration. AMS did not document or conduct the investigation, according to the April 10 letter recently posted online.
The letter goes on to cite risk analysis failures, noting that action items listed in a postmarket surveillance report on the AMS 800 were not completed. These include updating the design failure modes, effects and criticality analysis (dFMECA)-projected frequency of occurrence to reflect actual complaint rates.
The Minnetonka, Minn., company also failed to complete action items and meet time frame requirements for postmarket surveillance and risk-management activities on the AMS 700 Series Inflatable Penile Prosthesis.
And dFMECAs for that device were not updated to reflect current postmarket surveillance data after the release of a postmarket surveillance report. “Also, risk management reports for the IPP reservoirs, cylinders, and pump were not updated until 3/20/13, approximately 17 months after Post Market Surveillance Report D003504 was released on 10/31/11,” the letter says.
The FDA investigator noted several manufacturing processes and test methods for the AMS 800 Artificial Urinary Sphincter and AMS 700 Inflatable Penile Prosthesis had not been validated or had inadequate validations at the time of the inspection. In addition, several manufacturing processes and test methods for the AdVance Male Sling System, Ambicor 2-Piece Inflatable Penile Implant, Spectra Non-Inflatable 1-Piece Implant and Y-Mesh Sacral Colpopexy System were not validated.
Meanwhile, AMS could not locate a file for one of its corrective and preventive actions during the inspection and reconstructed it from the documents available. The company had expected to verify the effectiveness of the CAPA in January 2013, but acceptance criteria for the verification weren’t properly defined and verification had yet to be completed, the warning letter says.
After reconstructing the CAPA file during the inspection, AMS modified the acceptance criteria for the verification. The company evaluated the effectiveness of the CAPA and found the acceptance criteria were not met, so the CAPA was deemed ineffective, the letter notes.
AMS’ Form 483 responses indicate it has begun “comprehensive corrective actions” and, in a meeting with the FDA, “reiterated [its] commitment to taking corrective actions and achieving full, sustainable, compliance.” The agency will need to conduct a follow-up inspection to assess implementation and effectiveness of the corrections.
Brian O’Donnell, director of corporate affairs at parent company Endo Pharmaceuticals, said that “AMS self-identified the problem and has been working on it.” The company shared its remediation plan with the FDA in March and agreed on an accelerated approach to resolving the observations.
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