Summary

FDA Medical Device Inspection Observation Summary Published

Author:

Monitoring and Reporting Working Group

FDA has recently published their Medical Device Inspectional Observation Summary for FY2016.  This information can assist industry in improving device quality and compliance by:

  • Understanding key areas of noncompliance resulting from inspections
  • Identify possible areas of emerging concern
  • Possibly help firms to avoid receiving warning letters

Firms can also use this data to determine areas of the quality system that might be of focus in future inspections, identifying trends in FDA device inspections, and may drive priorities in internal self-inspections.

Number of 483s Issued from the System*

Inspections ending between 10/1/2015 and 9/30/2016

Center Name 483s Issued
Biologics 84
Bioresearch Monitoring 215
Devices 934
Drugs 691
Foods 2196
Human Tissue for Transplantation 92
Parts 1240 and 1250 97
Radiological Health 32
Veterinary Medicine 281
Sum Product Area 483s from System* 4622
Actual Total in System 483s** 4528

* This table does not represent the complete set of 483’s issued during the fiscal year as some 483’s were manually prepared and not available in this format. The sum of 483’s for all Product Areas will be greater than the actual Total 483’s issued during the fiscal year since a 483 may include citations related to multiple product areas, and counted more than once, under each relevant product center.

** This is the Actual Total number of 483’s issued from this system, and that are represented in this spreadsheet.

The top device inspectional observation citations by CFR reference issued by CDRH are listed below.  To review the complete list, click here.

Reference Number Short Description Long Description Frequency
21 CFR 820.100(a) Lack of or inadequate procedures Procedures for corrective and preventive action have not been [adequately] established. Specifically, *** 344
21 CFR 820.198(a) Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.  Specifically,*** 264
21 CFR 803.17 Lack of Written MDR Procedures Written MDR procedures have not been [developed] [maintained] [implemented].  Specifically, *** 146
21 CFR 820.90(a) Nonconforming product,  Lack of or inadequate procedures Procedures have not been [adequately] established to control product that does not conform to specified requirements.  Specifically, *** 135
21 CFR 820.50 Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established.  Specifically, *** 122
21 CFR 820.75(a) Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures.  Specifically, *** 119
21 CFR 820.100(b) Documentation Corrective and preventive action activities and/or results have not been [adequately] documented.  Specifically, *** 99
21 CFR 820.30(i) Design changes – Lack of or Inadequate Procedures Procedures for design change have not been [adequately] established.  Specifically,*** 78
21 CFR 820.22 Quality audits – Lack of or inadequate procedures Procedures for quality audits have not been [adequately] established. Specifically, *** 76
21 CFR 820.181 DMR – not or inadequately maintained A device master record has not been [adequately] maintained.  Specifically, *** 65
21 CFR 820.72(a) Calibration, Inspection, etc. Procedures Lack of or Inadequate Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established.  Specifically, *** 61
21 CFR 820.184 DHR – not or inadequately maintained A device history record has not been [adequately] maintained.  Specifically, *** 56
21 CFR 820.198(c) Investigation of device failures Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, *** 53
21 CFR 820.70(a) Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been [adequately] established.   Specifically, *** 53