Quality Procedures, Investigations Top FDA Drug Citations

Failures to establish or follow written quality procedures and inadequate investigations of manufacturing problems were the most frequently cited deficiencies in FDA drug-quality inspections conducted during 2026, according to an FDA Webview analysis of agency inspection data.

FDA cited deficiencies involving written quality-unit procedures in 74 inspections, representing 13.6% of the 546 drug-quality inspections included in the agency's publicly available inspection data through October 25. Inadequate investigations of unexplained discrepancies or manufacturing failures ranked second, appearing in 62 inspections, or 11.4% of the total.

The analysis follows two recent FDA Webview reports identifying and linking to 198 newly published Form FDA-483 inspection reports, including 26 reported 10/23 and another 172 reported 10/25. Those disclosures prompted a broader examination of FDA's 2026 drug inspection records to identify recurring manufacturing deficiencies.

For the analysis, each inspection was counted only once for each type of deficiency. The rankings therefore reflect the number of inspections in which a deficiency appeared, rather than the total number of individual citations.

Of the 546 drug-quality inspections identified, 216, or 39.6%, had at least one recorded citation. The figure reflects the agency's available public data and should not be interpreted as the overall rate of Form 483 issuance.

Most Frequently Cited Drug Manufacturing Deficiencies

Percentages are based on 546 distinct drug-quality inspections in FDA's public dataset. A single inspection may be counted in more than one deficiency category.

Company Inspections Illustrate Recurring Problems
Recent Form 483 reports illustrate the types of deficiencies appearing in FDA's inspection data. At Allure Labs, a 3/23–27 inspection of the company's Hayward, CA, manufacturing facility identified inadequate investigations of out-of-specification test results. According to the Form 483, investigators found that the company had changed product release specifications without adequately identifying the cause of the original failures or revalidating the manufacturing process. FDA also cited deficiencies involving computerized production and control records.

At Gilead Sciences, a 2/9–18 inspection of the company's La Verne, CA, manufacturing facility identified deficiencies involving the quality unit's oversight of stability studies. FDA investigators reported that long-term stability samples had been transferred from qualified environmental chambers to retained-sample rooms without adequate assurance that appropriate storage conditions would be maintained. The agency also cited the absence of scientific justification for the arrangement, according to the company's Form 483.

The observations are investigators' findings and do not constitute final FDA determinations of regulatory violations. They also do not establish whether the companies subsequently implemented satisfactory corrective actions.

Limitations of the Analysis
The analysis covers inspections conducted from 1/1 through 10/25 under FDA's Drug Quality Assurance inspection program that were included in the agency's publicly available inspection and citation datasets. These databases do not provide a complete accounting of every inspection or observation. Certain records may be withheld pending enforcement proceedings or delayed by redactions or other administrative processes.

The rankings measure citation frequency rather than inspection severity. A single inspection may include multiple deficiencies, and related GMP requirements may appear under separate regulatory citations. Consequently, the findings should not be interpreted as a comprehensive measure of industry compliance or as evidence that FDA has changed its inspection priorities.

Nevertheless, the data provide a year-to-date picture of recurring deficiencies in FDA's publicly disclosed drug-quality inspections, with written quality procedures and manufacturing failure investigations leading the citation categories.