The QMN Weekly Bulletin

Devicemakers Get 15 Warning Letters for CAPA, Complaint Violations

Sept. 16, 2016

The FDA has posted 15 new warning letters to device manufacturers for GMP violations: 14 to foreign manufacturers and one to a U.S. company.

The UK took the lion’s share of letters, receiving five, with China getting three letters, followed by Germany with two. Companies in Italy, France, Argentina and the Philippines received one warning letter each. The companies ranged from manufacturers of orthopedic implants, surgical cutting devices, carbon monoxide monitors and contact lenses to makers of menstrual cups and teeth whitening devices.

The FDA noted that it would refuse entry to 10 of the companies’ products until the required corrections were made, and it would not be approving PMAs for Class III devices for 11 of the companies that received warning letters.

The most-cited deficiency was failure to establish adequate corrective and preventive action procedures (21 CFR 820.100), with 11 firms receiving warnings.

The FDA made clear that fixing CAPA procedures would not be enough to satisfy inspectors. They expected to see retrospective analyses that documented past problems and that the firms understood the source of the failures. In addition, inspectors wanted the firms to address how they would remedy nonconforming products that had been released to the market.

The next-most-cited violation related to procedures for receiving, reviewing and evaluating complaints by a formal unit within the company. FDA handed out nine citations to companies for lax complaint procedures.

Third was design validation and verification procedures, which ensure design requirements meet specifications and their intended usage requirements.

Along these same lines, nine firms fell short when it came to maintaining device history records and device master records.

A number of firms received citations for failing to establish acceptance procedures to ensure that requirements for in-process products are met. Many also failed to document acceptance activities, the warning letters said.

Other firms failed to submit medical device reports or to establish written MDR procedures, the agency said. Other often-cited deficiencies included inadequate purchasing controls, failure to establish procedures for quality audits and failure to conduct necessary audits.

Highlights from the warning letters include the following citations:

  • China’s Master and Frank Enterprise submitted a Failure Mode and Effects Analysis risk analysis for its surgical drapes and gowns, but the FDA concluded that the FMEA was inadequate because it didn’t consider all potential hazards if the products didn’t conform to specifications. For example, it didn’t address potential biohazardous materials and physical contaminants that may be introduced from the surgical gowns into the surgical environment.
  • The UK’s Helica Instruments was cited for failing to establish and maintain adequate procedures to control nonconforming products. For example, the firm’s nonconforming product procedure didn’t adequately address the identification, documentation, evaluation, segregation and disposition of nonconforming product; nor did it address nonconformance evaluations and investigations or the need to notify those responsible for the nonconforming product, the warning letter says. The firm’s procedure also lacked detail when it came to rework and reevaluation activities, including whether there were any adverse events from the rework of the electrosurgical cutting and coagulation devices and accessories.
  • CAPA procedures and complaint handling were found lacking at Argentina’s F.P. Rubinstein Y Cia. The FDA noted that the firm’s CAPA procedure, which was opened to address validation records, was closed without performing the required validation. The letter noted that this was a repeat observation from an inspection in October 2014. The firm also failed to evaluate complaints of burns patients received from the firm’s laser-powered surgical instruments. The letter notes that eight out of eight complaints sampled did not include MDR evaluations, and four complaints did not have the phone number of the complainant or a description of the complaint. The agency noted that this also was a repeat observation. The firm also did not maintain device history records, which was another repeat observation, the warning letter said.
  • China’s Beyond Technology failed to establish procedures to prevent contamination of equipment or products, the warning letter said, drawing attention to rodent infestation in the buildings where teeth whitening devices and dental floss was manufactured.

Want to discover ways to improving your products and fending off the FDA? Order our publication Effective 483 Responses: Focus on CAPA Violations to learn more about satisfying CAPA requirements as humanly as possible.

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