This article presents the trends in drug GMP warning letters from fiscal years 2013 through 2016. Appendices 1- 4 provide tabulations of warning letters from each of the four 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 FY2016, ending September 31, 2016, are effective based on drug GMP warning letters posted by the FDA no later than November 1, 2016. The term ‘compounding pharmacy’ used herein also includes outsourcing facilities. This blog is a follow on blog entry (starting on page 4) from one published addressing FY2015 warning letter data.
The narrative and graphics address three broad areas:
- Type of manufacture (API, dosage form, API and dosage form, compounding pharmacy / outsourcing facility), country associated with the warning letter and for FY2016 whether and when an import alert was put in place and the intervals between inspection and imposition of the import alert.
- Percentage of warning letters that cite data integrity deficiencies and the countries where they are located and finally
- Interval between the inspection and issuance of the warning letter
- The number of drug GMP warning letters issued more than doubled over the previous year from 42 in FY2015 to 102 in FY2016. (Table 1 and Figure 1)
- The compounding pharmacy / outsourcing facility segment continues to receive disproportionate enforcement attention from FDA, receiving more than 50% of the warning letters for the third fiscal year in a row. This suggests that firms are not learning from the enforcement actions taken against others. (Table 1 and Figure 1)
- The number of warning letters issued to API manufacturers and dosage manufacturers is approximately…READ MORE…