Recently, the FDA’s Office of Inspections and Investigations published the FDA inspection summary for the fiscal year of 2025. Their overview focused on highlighting the topics where failures were more often identified.

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The study includes several product and program areas, however, for content harmonization we will focus on the drugs section.

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Some key takeaways include the fact that drugs’ Form 483 and observations are both the highest from the last five years. Also, the top-4 topics are exactly the same since 2021.

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The following topics were highlighted from the revision:

• procedures not in writing, fully followed – identified 243 times;
• investigation of discrepancies, failures – identified 164 times;
• absence of written procedures (162 times);
• scientifically sound laboratory controls (121);
• cleaning / sanitizing / maintenance (95).

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Taking this into account, we conducted a similar exercise considering the audits executed by Owlpharma (total of 80 audits within the same scope) in order to understand if the same trends are identified.

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During last year the highest identified findings in Owlpharma audits could be categorized as follows:

• cleaning / sanitizing / maintenance (38 times);
• procedures not in writing, fully followed (32 times);
• training, education, experience overall (20 times);
• environmental monitoring system (19 times);
• identification of equipment and lines (19 times);
• investigations of discrepancies, failures (18 times).

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Despite the shortest sample size, it is interesting to observe that some trends can be already identified and some of the highlighted topics of concern match the topics identified in the FDA overview. It is special important to highlight the concerns about “cleaning /sanitizing /maintenance”, “procedures not in writing, fully followed” and “investigations of discrepancies, failures”, topics that are present in both overviews.

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Regarding “cleaning /sanitizing /maintenance” the observations vary between missing or incomplete cleaning records, cleaning frequency not defined or not met and invalid or incomplete validations of cleaning procedures.

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The 32 observations identified related to written procedures not established or followed include, for example, overdue revision of SOPs, untraceable, inconsistent or incomplete records, and delayed document approval. Furthermore, deficiencies related to the investigation of discrepancies and failures were identified on 18 occasions across the audited sites.

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The overlaps identified between these two different analysis can give some valuable insights to the manufacturers to consider during training of their own teams in order to improve the overall compliance of the company.

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At last and for a better comprehension, we would like to emphasize the distribution of the findings according to the correspondent Eudralex Volume 4 Part I chapter and annex. Please refer to the graphic below.

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If you want to understand more about Owlpharma process or the overall audit service, please feel free to contact us, we will be happy to become a trustworthy and reliable auditing partner for your company.

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