This article presents a detailed summary and trends of FY2017 FDA drug GMP warning letters from fiscal years 2013 through 2017. Appendices 1- 5 provide tabulations of warning letters from each of the five fiscal years and identify product type covered in the letter, the issuing office, number of deficiencies identified, and the country in which the sites in question are located. Links are provided to each of the warning letters on the FDAwebsite.
The data for FY2017, ending September 31, 2017, are effective based on drug GMP warning letters posted by the FDA no later than October 25, 2017. The term ‘compounding pharmacy’ used herein includes outsourcing facilities.
The narrative, tables and graphics address four broad areas:
- Type of manufacture (API, dosage form, API and dosage form, compounding pharmacy / outsourcing facility), country associated with the warning letter and whether and when an import alert was put in place, the intervals between inspection and imposition of the import alert.
- Particular features of warning letters issued this year including those addressing combination products, homeopathic firms, cell and tissue firms and contracted operations.
- Percentage of warning letters that cite data integrity deficiencies and regions (US vs OUS) where recipient sites are located, and finally
- Interval between the inspection and enforcement actions including issuance of a warning letter or import alert.
EXECUTIVE SUMMARY: read more….