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The Most Common FDA Audit Findings From 2017
[Posted on: Thursday, January 11, 2018] Last year FDA conducted 17,487 audits worldwide, and issued 5045 FDA 483s, meaning that about 30% of the audits lead to non-compliance in more than one regulated area. There were 498 Warning Letters issues during the same time showing that 1 in 10 audits found repeat violations that required more serious enforcement action by FDA. SOP and documentation deficiencies were the dominant findings in FDA audits for almost all areas of compliance. Each year FDA publishes its list of audit findings for 9 major areas of compliance to help companies understand FDA’s key concerns. The list of audit findings released by FDA provides a unique insight into audit trends and key violations, helping companies evaluated if they are better prepared for an audit by FDA inspectors. Food facilities were found to have the most violations in 2017; the total number of 483s issued to food facilities was 2662, that is more than all other products combined. In food facilities, poor pest control and unhygienic practices accounted for almost 8 out of 10 findings. For the biologics and drug manufacturing facilities, SOP deficiencies were the top findings followed by poor documentation practices such as non-concurrent documentation, incomplete documents, poor organization, and missing documents. Many facilities involved with manufacturing drug and biologics were found to either not have well-written SOPs, or the SOPs simply not being followed properly. Training and inadequate CAPA practices were also common. Poor CAPA practices and inadequate complaint handling was found at more than half of the non-compliant medical device manufacturing facilities. Overall the medical devices facilities had almost double the number of 483s issued compared to drug manufacturing sites, while biologics had the least number of 483s. More than half of the non-complaint clinical trial sites had Principal Investigators who did not follow the written protocol, followed by poor patient records and source documents. About 25 percent of the non-compliant HCT/P manufacturing sites had poor donor screening followed by deficiencies in GTP compliance. Most of these findings should be not surprising to seasoned auditors as industry auditors have reported similar trends. The list of findings presents an overall picture and does not provide much detail of the specific concerns unlike Warning Letters that contain detailed description of the violations. The best use of the list of findings from FDA is to help create a list of areas to evaluate at internal reviews and audits. For example, food facilities should focus on pest control measures and sanitary practices during internal reviews while drugs and biologics manufactures should evaluate SOPs and training. These trends from 2017 are not new; in fact a review of the list of audit findings for the last 12 years show similar findings over all the years. So these are repeat concerns. What more could FDA do to increase awareness in the regulated industry!
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