Failure to Institute CAPA, MDR Procedures Draw Warning for Simpro
Failure to establish corrective and preventive action procedures as well as procedures for receiving and reviewing complaints landed Texas-based Simpro an FDA warning letter.
Although the manufacturer of non-invasive blood pressure monitors, fingertip pulse oximeters and portable fetal dopplers committed to developing a process and procedure for malfunctioning and returned products, its response didn’t demonstrate that it had developed a method to review the circumstances surrounding returned products to determine whether or not a CAPA investigation was necessary, the Aug. 17 letter said.
Similarly, the firm committed to establish a written complaint form, but it hadn’t committed to establishing procedures for receiving, reviewing and evaluating complaints by a formally designated unit.
Simpro’s response didn’t provide assurance that it had developed a method for reviewing the circumstances surrounding complaints it had received to determine if an investigation was needed. The letter noted that the firm also had not provided a date for establishing such procedures.
Moreover, the manufacturer didn’t have any written Medical Device Reporting procedures, the warning letter said, and it didn’t provide adequate detail in its response about when it would establish MDR procedures or that it had reviewed complaints to see if they were reportable.
The letter noted that a follow-up inspection may be required to verify that the corrections have been implemented.
In addition, FDA inspectors reviewed Simpro’s website and found some of the language describing the products to be misleading, causing the company’s products to be misbranded.
For example, the firm said its portable fetal doppler was “FDA approved,” but the agency said that language was misleading because the device didn’t go through the premarket approval process. The agency asked the company to provide evidence that it did go through the PMA process or to remove the “FDA approved” reference from marketing materials.
In another example, the firm refers to its oximeters on its website as “not a medical device,” but Simpro lists the products with FDA as Class II devices. The agency requested an explanation for the discrepancy.
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