Most Common FDA 483 Violations for Medical Devices
September 9th, 2013 // 10:04 pm @ jmpickett
According to recent FDA CDRH information, the most common 483 violations in the medical device industry are the following:
- Corrective and preventive action procedures (CAPA) – CFR 820.100(a)
- Complaint procedures -Â CFR 820.198(a)
- Corrective and preventive action documentation – 820.100(b)
- Process validation – 820.75(a)
- Written MDR procedures – 803.17
Below are more details of each area.
CAPA
21 CFR .20.100(a) mandates that proper procedures be set up for CAPAs. Deficiencies that FDA has found in recent months include companies not analyzing processes, service records, QA reports, returned product, complaints and other sources of quality data to ID instances of nonconforming product. Companies also fail to ID various other quality problems, and fail to investigate why a nonconformity occurred.
Complaints
21 CFR 820.198)a) mandates that a medical device company has to set up procedures to receive, review and evaluate complaints, and this must be done by a designated unit of the company. Companies often are cited for not processing complaints on time; not documenting complaints; and not evaluating complaints to see if they must report them under FDA’s MDR regulations.
CAPA documentation
21 CFR 820.100(b) requires that a company must document CAPA activities and results. Companies often will take CAPA action but will not maintain documentation.
Validation
21 CFR 820.75(a) mandates that firms validate processes when the results cannot be verified by a later test and inspection. Medical device companies often are cited for not validating processes when they manufacture their devices.
MDRs
21 CFR 803.17 requires that a medical device firm maintain and implement proper MDR written procedures. Companies often are cited here for not having complaint handling procedures have a description of how the complaints will be reviewed for whether or not they are MDR reportable; and actually doing the filing of the MDR reports.
For information on how to handle CAPAs and CAPA documentation, please see our Sept. 26 webinar, How to Design an Effective CAPA Program. Regarding validation, see our Sept. 26 webinar, FDA-Compliant Strategic Software Validation Planning for Senior Management.
