483 Roundup: FDA Flags Three Firms for MDRs, Other Violations
The FDA cited three device companies for medical device reporting, corrective and preventive actions and other violations found during inspections.
Alba Bioscience: Alba Bioscience did not properly implement medical device reporting procedures or document control procedures, the FDA said following a September 2018 inspection.
The FDA issued a Form 483 following its inspection of the firm’s Edinburgh, Scotland facility and found it had not implemented medical device reporting procedures for several licensed in vitro diagnostic devices, including blood grouping reagents, reagent red blood cells and anti-human globulin. The inspection also determined the facility had not established controls for electronic data acquisition systems and found a failure to prevent unauthorized access of changes to data. The company also did not establish procedures for issuing and reconciling batch manufacturing records or QC test record forms used to document device production and testing.
Moreover, the company’s procedures for non-viable particle monitoring during filling operating did not ensure meaningful data were collected and the required sample collection was not clearly defined in either written procedures or the sample map.
Thermogram Assessment Services: The FDA cited Thermogram Assessment Services for problems with its CAPA, complaint-handling and MDR procedures.
The agency inspected Thermogram’s Dallas facility in October 2018 and found it lacked a CAPA procedure or complaint handling procedure, according to the Form 483. The inspection also determined the facility lacked compliant process control procedures to ensure conformance to specifications.
In addition, the company lacked procedures for medical device reporting and for purchasing controls to ensure all received products and services met specified requirements.
OCCK: The FDA issued device manufacturer OCCK a Form 483 for issues with its Salina, Kansas facility’s quality system management and device history records.
The investigator, who inspected the firm from Aug. 8-9, 2018, found that the facility had not documented the appointment of a management representative to ensure that quality system requirements are fulfilled.
The firm was also called out for device history records, which lacked identification labels and labeling, such as batch numbers.
OCCK was also cited for its document control procedures, which lacked evidence that a designated individual reviewed and approved them. These included manufacturing, packaging and sub-contract work corrective action plan, medical products complaint process, quality management system and management review of quality system for medical device product procedures.
Additionally, the firm’s CAPA standard operating procedure lacked certain requirements. Specifically, it didn’t require the analysis of quality data to pinpoint existing and potential causes of nonconforming product and didn’t require investigating the cause of nonconformities, identifying actions to correct and prevent repeated nonconformance, and other quality issues.
Read the Alba Bioscience Form 483 here: www.fdanews.com/01-18-19-albabioscienceltd483.pdf.
Read the Thermogram Form 483 here: www.fdanews.com/01-18-19-thermogram483.pdf.
Read the OCCK Form 483 here: www.fdanews.com/01-17-19-occkinc483.pdf.