483 Roundup: Four Devicemakers Cited for Inadequate Procedures
The FDA issued Form 483s to Jensen Industries, Tyson Bioresearch, OsteoSymbionics and Innovative Sterilization Techniques, citing problems with their procedures for corrective/preventive actions, complaints and MDRs.
Jensen Industries: Jensen Industries landed a Form 483 due to issues with corrective/preventive actions and quality system reviews.
The FDA issued the form following a March inspection of the firm’s North Haven, Conn., facility. According to the agency, Jensen failed to follow its SOPs on corrective/preventive actions (CAPA). A CAPA initiated in July 2015, for example, failed to document the effectiveness of the action the company took in the specified time frame, while two CAPA actions opened in 2016 are still open past their due dates of February 2017, with no documentation justifying the continued openness.
Moreover, investigators found executive managers did not review Jensen’s quality system, in contrast with the firm’s SOPs, which require regular management reviews. In one case, the firm conceded one of the management reviews was not performed according to the established schedule. Jensen promised to correct both observations.
Tyson Bioresearch: The FDA hit Tyson Bioresearch on several of its procedures, including corrective actions, complaints, validation processes and written MDRs.
The agency issued a Form 483 after a March inspection of its Chun-Nan, Miaoli County, Taiwan, facility. According to investigators, the facility failed to initiate certain corrective and preventive actions in 2015 and 2016, contravening its own quality objectives.
The facility also did not validate a process used in the manufacturing of its glucose test strips according to its established procedures, and has yet to establish several procedures that describe the process controls necessary to ensure adherence to specifications.
Further, investigators found complaints from 2016 and 2017 for Tyson’s Blood Glucose Monitoring System that, contrary to the company’s SOP, did not contain documented evidence of MDR evaluation. The FDA also faulted Tyson’s written MDR procedures, noting its MDR procedures are simply a copy of the U.S. FDA MDR regulation.
OsteoSymbionics: The FDA issued a Form 483 to OsteoSymbionics for numerous procedural problems with corrective/preventive activities, nonconforming materials and equipment calibration.
OsteoSymbionics landed the form shortly after a March inspection of its Cleveland facility. According to FDA investigators, the firm has not yet completed a corrective/preventive action opened in June 2015, and there is no documented evidence the CAPA in question, which involved updating milling procedures, took place.
The facility’s nonconforming material reports (NCMRs) are also incomplete and do not meet the company’s NCMR procedures’ requirements. A review of 14 NCMRs found 10 did not document the decision not to investigate and three failed to fill out the investigation and approval sections.
Investigators also found information missing in the facility’s supplier files, including lack of supplier evaluation records, outdated ISO certification files and missing ISO certificates.
Lastly, the facility’s Heat Sealer equipment, used for sterile packaging of cranial implants, was calibrated for time and temperature but not for pressure. OsteoSymbionics promised to correct all observations.
Innovative Sterilization Technologies: Innovative Sterilization Technologies landed an FDA Form 483 that cites inadequate corrective/preventive action (CAPA) procedures, complaint handling, MDR procedures and incoming product acceptance.
The agency issued the form after a March/April inspection of the company’s Dayton, Ohio, facility. Inspectors noted that the company’s CAPA procedures do not clearly define the meaning of “unfavorable trend,” nor have its evaluations of CAPAs ensured the actions were effective and did not adversely affect the finished device.
The facility’s complaints procedure, meanwhile, does not define how to document complaint investigations or closures of warranty complaints for products that were not returned for assessment. Since last July, the company has “voided” nearly 50 warranty complaints because no product was returned.
The agency also found the acceptance test performed on Innovative Sterilization’s tamper locks is not clearly defined and references a standard operating procedure that is still in draft form. Similarly, its written MDR procedure has no standardized review process or a method of evaluating when a complaint should be reported as an MDR.
The 483s can be read here: www.fdanews.com/06-21-17-roundup483s.pdf. — Zack Budryk