FDA Warning Letter Audit By HHS

The Office of the Inspector General at the US Department of Health andSocial Services has begun to examine consistency in the issuance of warning letters at several Food and Drug Administration district offices, reports Health News Daily. The probe will cover all types of warning letters issued to all industries regulated by the FDA.

The OIG is examining the effectiveness of FDA center and district warning letter programs, including the timeliness of issuing letters after an inspection, conformance with FDA policy and effectiveness in achieving compliance. It has conducted an entrance interview with the FDA Office of Regulatory Affairs, which oversees field operations, has requested information in the FDA warning letter database and is currently collecting information from the FDA district offices.

The audit is a response to long-standing industry complaints that FDA district offices use different criteria for deciding whether specific violations should trigger a warning letter. The FDA delegated authority for issuing most types of warning letters to its district offices in 1991. The OIG, which has been planning the audit since 1996, notes that "regulated industry has alleged that variations exist across the different district offices of FDA."