But as data released by the FDA shows some problems are far more common than others, illustrating areas where the industry can make outside improvements. Data taken from FDA’s inspectional database between 1 October 2012 and 30 September 2013 showed a total of 5,211 FDA Form 483s, the form FDA uses to note deficiencies at a manufacturing facility.
| Center Name | 483s issued |
| Foods (CFSAN) | 2386 |
| Devices (CDRH) | 1099 |
| Drugs (CDER) | 690 |
| Veterinary Medicine (CVM) | 328 |
| Bioresearch monitoring | 273 |
| Biologics (CBER) | 191 |
| Human tissue for transplantation | 121 |
| Parts 1240 and 1250 | 91 |
| Radiological Health (CDRH) | 32 |
| Total | 5211 |
But as we said before, some violations tend to pop up more than others, in some cases hundreds of times each year. In the medical device sector, for example, 378 inspections showed that corrective and preventive action (CAPA) procedures had not been put into place, raising FDA’s concerns that problems might occur over and over again.
Below are the top 10 inspection violations found during inspections of medical device, pharmaceutical, biologic, veterinary and bioresearch facilities.
Medical Device: Top 10 Inspection Violations
| Regulatory Reference | Frequency | Short Description | Long Description |
| 21 CFR 820.100(a) | 378 | Lack of or inadequate procedures | Procedures for corrective and preventive action have not been adequately established. |
| 21 CFR 820.198(a) | 245 | Lack of or inadequate complaint procedures | Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established. Specifically, *** |
| 21 CFR 820.100(b) | 133 | Documentation | Corrective and preventive action activities and/or results have not been adequately documented. |
| 21 CFR 820.75(a) | 127 | 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. |
| 21 CFR 803.17 | 124 | Lack of Written MDR Procedures | Written MDR procedures have not been developed maintained implemented. |
| 21 CFR 820.50 | 110 | 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. |
| 21 CFR 820.90(a) | 98 | Nonconforming product, Lack of or inadequate procedures | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| 21 CFR 820.30(i) | 93 | Design changes – Lack of or Inadequate Procedures | Procedures for design change have not been adequately established. Specifically,*** |
| 21 CFR 820.181 | 77 | DMR – not or inadequately maintained | A device master record has not been adequately maintained. |
| 21 CFR 820.22 | 73 | Quality audits – Lack of or inadequate procedures | Procedures for quality audits have not been adequately established. |
Drugs: Top 10 Inspection Violations
| Regulatory Reference | Frequency | Short Description | Long Description |