483 Suggests Disregard for FDA Procedures, Recordkeeping
An FDA inspection of Salt Lake City-based BioMeridian International found 16 observations — most in the form of missing procedures or documentation.
Quality system procedures and instructions had not been established, and there were no management review procedures or designated management representative. The company had not performed an internal quality audit since spring 2007, the Form 483 states.
BioMeridian’s complaint files were also found to be lacking, with no written procedures to ensure complaints were documented upon receipt, evaluated to determine if they needed to be reported to the FDA under MDR regulations and investigated when necessary. Device names and serial numbers were absent from the complaint files.
Failure to validate device software may have raised a red flag on the scope of the company’s deviations, as its main products — the Professional, Vantage and Vantage Pro Galvanic Skin Response measurement devices — are hardware platforms paired with software to measure patient functioning.
Other missing or inadequate documents noted on the 483 included:
- Corrective and preventive action procedures;
- Servicing activity procedures;
- Device master records;
- Device history record procedures;
- Procedures for acceptance of incoming product;
- Procedures to control product that does not conform to specified requirements;
- Procedures to rework nonconforming product, even though BioMeridian does rework nonconforming devices;
- Design control procedures; and
- Document control procedures.
Inspectors also cited BioMeridian for inadequate supplier evaluation standards and the lack of supplier agreements ensuring the company’s notification of product changes, the Form 483 states, and the company had no training documents or method for identifying training needs.
The Form 483 was issued on Nov. 22, 2011, at the conclusion of an inspection that began on Nov. 10. BioMeridian could not be reached for comment by press time. — Elizabeth Orr
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