Inspections, Compliance, Enforcement, and Criminal Investigations
If any PMA devices are manufactured at the facility being inspected, determine whether this manufacturing site was approved in the original PMA or a PMA supplement, even if only partially manufactured at the inspected site. Report discrepancies in the EIR and notify CDRH, HFZ-306 (Field Programs Branch)..
A determination must be made as to whether the firm manufactures any devices required to maintain device tracking data (see CP 7382.830 Attachment D). If so, determine whether the firm has device tracking procedures in place and if they are adequate to assure each device required to be tracked will be tracked to the actual end user, i.e. the patient. One method to do this would be to obtain a list of devices distributed during a given time frame and then look for those devices in the tracking database.
If there is a complete lack of a tracking system, this should be cited on the FDA 483. Other observations should be discussed with the firm's management and reported in the EIR. The EIR must indicate whether or not the inspected firm makes any device subject to the device tracking requirements. If so, the EIR must include a statement that the firm's procedures, tracking database, etc. were assessed for compliance to the
Medical Device Tracking Requirements (21 CFR 821). All FDA 483s or EIRs with medical device tracking observations must be sent to CDRH/Office of Compliance, Field Programs Branch (HFZ-306).
A comprehensive inspection is required to be done when performing a compliance inspection (OAI follow-up inspection) of a firm. It must include all of the items discussed under Directed Device Inspections as well as a determination of whether all previous FDA 483 observations have been investigated and corrective action has been implemented. Additionally, all other quality system requirements in the QS/GMP regulation should be inspected for compliance.
All requirements of the QS/GMP regulation apply equally to manufacturers, large and small, foreign and domestic, of finished medical devices. Manufacturer includes any person or firm that designs, manufactures, fabricates, assembles, or processes a finished device. Remanufacturers (performs any act to a finished device that significantly changes the device's performance or safety specifications or intended use) must also comply with the QS/GMP regulation. Currently, they do not apply to refurbishers or third-party servicers (performs any act outside of the control of the original equipment manufacturer (OEM) that only restores the finished device to its original performance or safety specifications or intended use, or does not significantly change the original performance or safety specifications or intended use).