Environmental Tectonics: A litany of good manufacturing practices lapses related to documentation and validation resulted in a seven-item Form 483 for Environmental Tectonics following an inspection of its Southampton, Pennsylvania facility.
The company manufactures industrial sterilizers as well as test chambers.
FDA inspectors observed service reports that represented medical device reportable events that were not considered complaints and processed as such. For example, one service report documented a broken handle on a hyperbaric chamber in which a patient was locked for about 20 minutes. A user facility adverse event was filed with the FDA, but no information was available in the service report concerning the medical impact on the patient, the agency said.
In addition, a review of the service report log noted that a previous complaint describing a patient locked inside a hyperbaric chamber was documented about six months earlier.
In a separate observation, a field steam sterilizer, which was designed and labeled for sterilizing porous and nonporous heat and moisture stable surgical instruments, was not properly validated, and there were no performance data available to ensure the device met its intended purpose. No verification specifications were documented in the firm’s acceptance activities.
Other records were missing for the steam sterilization device, including device history records and test checklists.
A device history record for another instrument, the bara-med monoplace hyperbaric chamber, didn’t refer to the location of a unique device identifier or universal product code. Other devices were also lacking information on UDIs and UPCs, the investigators said.
Xodus Medical: Numerous complaints for unsealed cautery tip cleaning surgical devices were not documented as complaints, and validation procedures were found to be lacking at Xodus Medical during an inspection of its New Kensington, Pennsylvania plant.
The maker of surgical equipment failed to review, evaluate and revalidate its production process for sealing when changes and process deviations occurred. When products were returned due to failure to meet their specifications, these complaints were not reviewed, evaluated or investigated, the FDA said.
The agency investigators said the firm’s production processes were “not conducted, controlled and monitored to ensure that a device conforms to its specifications.” Equipment used in production was causing unsealed packaging of sterile products, and lots were not inspected before being shipped and released.
Between Nov. 1, 2016 and July 25, 2019, the company received 453 Returned Goods Authorizations (RGA) for products, but the RGAs were “not all shared or provided to the department responsible for evaluating complaints,” and they were not reviewed and evaluated to determine if the reported failures required documenting a complaint, the 483 said.
In addition, corrective and preventive action activities were not documented, and procedures for rework of nonconforming product were not established, the FDA said.
Bellaire Aesthetics: Bellaire Aesthetics didn’t establish procedures for receiving, reviewing and evaluating complaints, an FDA inspection of the firm’s Middle Island, New York facility revealed.
The company makes skincare devices, such as microneedle devices for aesthetic purposes.
The three-item 483 cited the firm for not establishing written procedures that describe how it stores products to prevent potential mix ups.
During the inspection, investigators observed that the storage area “did not appear to be organized,” and there were no specific product placement or quarantine areas. The 483 noted that the devicemaker discontinued selling certain medical devices that were still being stored in its inventory alongside products that were currently offered for sale.
Investigators also observed that the company had not established any complaint procedures to specify how the firm receives, reviews, evaluates and maintains complaints.
The manufacturer also failed to establish medical device reporting procures for evaluating and investigating complaints or for reporting adverse events to the FDA.
Read the Environmental Tectonics Form 483 here: www.fdanews.com/11-21-19-environmentaltectonicscorp483.pdf.
Read the Xodus Medical Form 483 here: www.fdanews.com/11-21-19-xodusmedicalinc483.pdf.
Read the Bellaire Aesthetics Form 483 here: www.fdanews.com/11-21-19-bellaireaestheticsinc483.pdf.
Tips for Managing Complaint Investigations
Once a complaint is deemed potentially reportable as a medical device report (MDR), a designated individual within the complaint handling unit must promptly begin an investigation.
The skill set for an MDR investigation is specialized and different from skills required for other investigations, so it is important that devicemakers carefully select and train employees to conduct MDR investigations, according to quality expert Dan O’Leary, president of Ombu Enterprises.
The investigation must determine whether the device failed to meet a specification. If so, it must ferret out the root cause of the inadequacy. It also must examine the relationship of the device to the reported incident or adverse event.
The investigation should conclude with a determination of whether or not a CAPA is needed. The complete results of the investigation must be included in the MDR event file and the regulations require an individual MDR record for each event. The information is collected in the MDR event file, which is linked to at least one individual complaint record.
If there are multiple complaints about the same issue, the MDR event file for that issue or event could be linked to multiple individual complaint records. These files need to include all information about the adverse event, such as documentation, deliberations, reportability decision-making, information submitted to the FDA and acknowledgements that the MDR was successfully uploaded to the FDA database.
FDA employees must be allowed to access, copy and verify these records. It is acceptable for the MDR event file to be part of a complaint file. In such cases, the devicemaker must clearly identify the complaint file as having an associated or included MDR event file.
Excerpted from the FDAnews management report: Complaint Management for Devicemakers: From Receiving and Investigating to Analyzing Trends.