The Top 15 Medical Device Deficiencies Cited by FDA in 2014
The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of medical device facilities, indicating the most common issues faced by medical device companies.
Total 483s Issued Declines for First Time in Six Years
In its most recent report, FY 2014 Inspectional Observation Summaries, FDA said it issued 972 Form 483s—forms indicating areas of noncompliance at a facility—to medical device companies in fiscal year 2014.
The number of 473s issued (972) marked the first year since FY 2008 that FDA has issued fewer 483s than the year prior, and is the least issued since FY 2010 when FDA issued 976.
The Top 15 Medical Device Deficiencies in FDA's 483 Reports
FDA's inspections also noted common deficiencies at medical device manufacturers.
| Regulatory Citation | 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. | 360 |
| 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,*** | 251 |
| 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. | 129 |
| 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. | 122 |
| 21 CFR 803.17 | Lack of Written MDR Procedures | Written MDR procedures have not been [developed] [maintained] [implemented]. | 117 |
| 21 CFR 820.100(b) | Documentation | Corrective and preventive action activities and/or results have not been [adequately] documented. | 101 |
| 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. | 100 |
| 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures | Procedures for design change have not been [adequately] established. Specifically,*** | 95 |
| 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures | Procedures for quality audits have not been [adequately] established. | 90 |
| 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. | 68 |
| 21 CFR 820.25(b) | Training - Lack of or inadequate procedures | Procedures for training and identifying training needs have not been [adequately] established. | 61 |
| 21 CFR 820.40 | Procedures not adequately established or maintained | Document control procedures have not been adequately [established] [maintained]. Specifically,*** | 61 |
| 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures | Procedures for management review have not been [adequately] established. Specifically,*** | 60 |
| 21 CFR 820.181 | DMR - not or inadequately maintained | A device master record has not been [adequately] maintained. | 58 |
| 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures | Procedures for finished device acceptance have not been [adequately] established. | 55 |