483 Roundup: FDA Cites Five Firms for MDRs, Other Issues
The FDA flagged several U.S. and international facilities for a range of deviations including inadequate complaint procedures, MDR reporting, and recordkeeping.
Hand Biomechanics: The FDA issued a Form 483 to Hand Biomechanics, citing problems with its complaint process and failure to submit MDR reports.
The agency issued the form following a June/July inspection of the firm’s Sacramento, Calif., facility. Investigators found the company did not submit an MDR report within 30 days of receiving information suggesting its devices may have contributed to injuries or deaths.
The FDA found that in handling complaints, the firm failed to include all information required in its own complaint procedures. Furthermore, the firm’s process for package sealing was not properly validated and its processes were not revalidated in the wake of changes or process deviations.
The agency also faulted the company on its CAPA handling, finding 10 cases where it failed to prevent recurrences of quality problems.
Neuro-Fitness: The FDA dinged device manufacturer Neuro-Fitness for complaint handling and ensuring device conformance.
The agency hit the company with a Form 483 following a July inspection of its Fall City, Wash., facility. According to investigators, the firm currently used an unapproved version of its complaint form that was missing sections on complaint investigation requirements, responses to complainants and required corrective actions.
Lastly, the firm’s procedure for purchasing controls required regular re-evaluation of suppliers for acceptability as well as for the company to keep an approved vendor list, but Neuro-Fitness failed to document re-evaluations or keep such a list.
Ever Corporation: An Ever Corporation facility in Kuroiso City, Japan drew a Form 483 following an FDA inspection in February for a range of deficiencies including a lack of written MDR procedures, and failure to establish procedures for device history records and records of acceptable suppliers.
The site inspection also revealed that several nonconformities that occurred while assembling products had not been documented or investigated.
AMD Medicom: The FDA cited AMD Medicom for lacking adequate procedures for CAPA actions, and for failing to maintain a device master record and to establish contamination prevention procedures.
The facility in Granby, Quebec had signed as completed, closed and/or verified as effective certain CAPA actions for customer complaints over issues such as “material falling apart” even though implementation of the actions had not been documented, the FDA investigator found.
In addition, the facility’s device master record for ophthalmic sponges lacked device specifications, product process specifications, quality assurance specifications, and packaging and labeling specifications.
Diagnostic Grifols: The FDA flagged the Diagnostic Grifols manufacturing facility in Barcelona, Spain, for nonconformities relating to MDR reporting, and evaluations of potential suppliers, following an inspection carried out from Feb. 13-16.
It took the company 201 days to submit an MDR report from the day it became aware of the device malfunctioning incident with information that reasonably suggested the device could have contributed to a death or serious injury.
In addition, the firm failed to provide valid statistical justification for the sampling method used for inspecting incoming raw material, according to the Form 483.
Read the five Form 483s here: www.fdanews.com/09-28-17-FiveForm483s.pdf.