483 Round Up: FDA Cites Three U.S. Facilities Over CAPA, Other Issues
Strata Skin Sciences failed to report a correction or removal to the FDA and committed other violations, according to agency inspectors.
The FDA investigator visited the company’s Carlsbad, Calif., facility in December 2016 and observed in a Form 483 that the company failed to report the details of a CAPA action in response to a customer complaint that the company’s XTRAC Excimer Laser System fired randomly.
The complaint was submitted to the FDA as a malfunction that could result in serious injury if it were to recur. Although the CAPA states that steps were taken to avoid a recurrence, including a design change, the correction was not reported to the FDA.
The Form 483 also reported that the company failed to review all the circumstances that led to the random firing issue for the Excimer Laser System, including additional complaints for similar issues received during the investigation period. Moreover, the procedure did not require verification of all corrective actions to ensure they were effective.
The inspector also faulted Strata’s medical device reporting procedures, which did not require documentation and recordkeeping of information evaluated to determine if an event was reportable.
In addition, the company’s risk management process did not include documentation showing that complaints were evaluated to determine new or increased risks to patients.
Other observations included: (1) requirements to ensure that finished devices were held until authorized signatures were obtained and other procedures were completed; (2) complaints were closed without documentation that returned products had been evaluated; and (3) class designations and warnings were not provided in product brochures.
US Endoscopy: US Endoscopy Group failed to properly document CAPA procedures and committed other violations, according to a Form 483.
Following an inspection of the company’s Mentor, Ohio, facility in November and December 2016, inspectors observed that the facility did not conduct appropriate CAPAs for two situations.
In a post-production data analysis for the Raptor Grasping device, the company concluded based on an MDR summary, the calculated incident rate was higher than expected. But it failed to document any review or mitigation steps. Another CAPA for defects in gauge needles lacked full documentation of a root cause assessment, including corrective actions, preventive actions and verification/validation activities.
The Form 483 also noted that US Endoscopy’s complaint investigation procedure did not clearly define how and when risk assessments were reviewed and updated. For example, documentation stated that a complaint was reviewed and the associated hazards were identified, but there was no documentation of whether the event fit the identified risk profile or if the risk assessment needed updating.
Fundus Photo: The FDA slapped medical device company Fundus Photo with a Form 483, citing procedural and record-keeping failures.
In a December 2016 inspection of the medical device manufacturer’s Lenexa, Kans., facility, FDA inspectors uncovered numerous problems with records. For example, the facility did not keep adequate device history records, and failed to maintain formal complaint investigation records or master device records. The agency noted an issue with master records in a previous inspection.
The inspection also uncovered numerous procedural issues at the facility.
Read the Strata Form 483 here: www.fdanews.com/03-13-17-Strata.pdf.
Read the US Endoscopy Form 483 here: www.fdanews.com/03-13-17-USEndoscopy.pdf.
Read the Fundus Form 483 here: www.fdanews.com/03-17-17-fundusphoto483.pdf. — Zack Budryk