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News about GMP/cGMP

FDA: Warning Letter Enforcement Begins in September

The US Food and Drug Administration announced a new program regarding the issuance of warning letters to the pharmaceutical industry. Published in the Aug. 11 Federal Register, the program is meant to better support public health protection by establishing a timeframe for “the submission and agency review of post-inspection responses to inspectional observations” that are sent to a company via a FDA 483 form, according to the Register.


FDA 483 forms are issued to companies after an inspection to highlight “objectionable conditions” relating to the manufacturing process or products, according to the announcement. Companies are asked to respond to FDA if they have an objection to an observation or if they have a corrective action plan for the observations noted. Warning letters, on the other hand, are issued when the agency, after a thorough review, finds a significant violation of the Federal Food, Drug, and Cosmetic Act during an inspection.

Because a company’s response—or in most cases, multiple responses—to an FDA 483 form can delay the issuance of a warning letter, the agency is now planning to issue a warning letter—when appropriate—if the company fails to respond to a 483 within 15 business days. If a response to a 483 is received within 15 business days, FDA will conduct a review of the response “before determining whether to issue a warning letter.”

If a warning letter is still issued after receiving a firm’s timely response to 483 observations, the warning letter will recognize that response. If 483 observation responses are received after the 15-day period, and the agency issues a warning letter, FDA will consider those responses to be direct responses to the warning letter rather than to the 483.

FDA reiterates in the announcement that the agency can issue a warning letter at any time, independent of receiving a 483 response.

The program, which correlates directly with FDA Commissioner Hamburg’s annoncement on August 6, of a six-step improved enforcement plan (see related story, FDA Commissioner Outlines Six-Step Plan for Improved Enforcement.), takes effect Sept. 15, 2009. The program will be evaluated after an 18-month period.

by: Angie Drakulich

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