483 Roundup: FDA Cites Seven Firms for Procedural Issues
The FDA issued Form 483s to seven device facilities for a range of deviations including noncompliance with their SOPs and problems with complaints and equipment maintenance.
Oxford Performance Materials: The FDA cited Oxford Performance Materials for five issues from environmental control procedures to equipment maintenance.
The agency issued a Form 483 to Oxford’s South Windsor, Conn., facility, following a March/April inspection. According to investigators, the facility did not conduct cleaning validation for the compound used to clean its HTR-PEKK cranial implant to ensure the compound’s effectiveness. Investigators also observed a bag of the material used to finish the implants that was ripped and repaired with packing tape, and receiving records indicated acceptance of material without a record of inspection.
The facility also failed to established acceptance criteria for monitoring viable and non-viable samples, and its process validation for pre-vacuum steam sterilization for cranial implants did not include the review and approval of the report.
Biowave: The FDA cited Biowave for its quality audit procedures and management review.
The agency conducted an April inspection at the devicemaker’s Norwalk, Conn., facility and found the company’s had not established procedures for internal quality audits, a repeat observation.
Neurotron: The FDA issued a Form 483 to Neurotron over problems with its product instructions and failure to calibrate equipment.
In an April inspection of the devicemaker’s Pasadena, Md., facility, inspectors noted the company’s repair order instructions for its products did not provide adequate instruction and none of the 10 service reports reviewed documented who serviced the device or the test and inspection data.
The FDA also faulted the device manufacturer for its calibration procedures. The firm failed to follows its own SOPs on calibration.
TAG Medical Products: During a March inspection, investigators reviewed 14 complaints received by TAG Medical Products between November 2012 and March 2017 at its facility in Ha Zafon, Israel. Four of the complaints constituted adverse events according to TAG’s description, but they were not documented as such or reported to the FDA, a March inspection found.
Direx Systems Corp.: Similarly, Direx Systems Corp. did not include required information in its service reports, according to the FDA. An April inspection of the company’s Canton, Mass., facility found that while the firm’s service procedures require documentation for all tests, the information was not included for several service records.
Avery Biomedical Devices: An April inspection of Avery Biomedical Devices’ facility in Commack, NY found the firm did not comply with its clean room control procedures and lacked humidity or temperature monitoring devices in the clean room.
Transoject: A March inspection of Transoject’s facility in Neumunster, Germany, found the firm failed to adequately assess whether a complaint qualified as a reportable adverse event.
Read the full Form 483s here: www.fdanews.com/07-07-17-Seven483s.pdf. — Zack Budryk