Questions and Answers
Merck Warning Letter
FDA's Electronic Freedom of Information Reading Room - Warning Letters and Responses
When did FDA first become aware of issues with Merck and Co described in the April 28, 2008 Warning Letter?
FDA conducted an inspection of Merck and Co.'s West Point, PA, facility between November 26, 2007, and January 17, 2008.
What issues did the agency identify during the inspection?
FDA investigators documented significant deviations from current good manufacturing practice in the manufacture of licensed vaccines, bulk drug substances and drug components. At the conclusion of the inspection, investigators issued a list of inspectional observations (FDA Form 483) to the firm, which included but was not limited to inadequate investigations of deviations and failure to maintain production and process controls. After determining that the firm's response to the FDA Form 483 was inadequate to address the serious deviations noted, FDA issued the Warning Letter. FDA is continuing its discussions with the firm on an ongoing basis.
Why did FDA issue this warning letter?
FDA's practice, depending upon the nature of a violation of regulations, is to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. The use of Warning Letters and the prior notice policy are based on the expectation that most individuals and firms will voluntarily comply with the law.
Warning Letters are issued only for violations of regulatory significance. Significant violations may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency's principal means of achieving voluntary compliance with applicable laws and regulations.
What products are covered by this Warning Letter?
The Warning Letter covers U.S. licensed biologics manufactured by Merck at the West Point, PA facility, including but not limited to the following vaccines: Liquid PedvaxHIB®, RECOMBIVAX HB®, ProQuad®, Gardasil®, VAQTA®, and COMVAX®.
Does this mean Merck's vaccines will not be available?
At this time, the deficiencies noted in the inspection of Merck's West Point, PA, manufacturing facility are not expected to affect the availability of the firm's licensed vaccines, with the exception of PedvaxHIB and COMVAX, which were recalled by the firm in December 2007. (See CBER's shortage page at http://www.fda.gov/cber/shortage/shortage.htm for further information.) At that time, Merck noted that it expected to resume distribution of these vaccines in the fourth quarter of 2008. We will continue to review the progress made by the company.
Does this mean that Merck's vaccines are unsafe?
No. FDA does not believe that the issues identified will affect the safety of the vaccines manufactured by Merck. We will continue to review the progress made by the firm.
Are other Merck manufacturing facilities included in this warning letter?
No, only Merck's West Point, PA, manufacturing facility is subject to this Warning Letter.
What is Current Good Manufacturing Practice (CGMP)?
CGMP provides for the methods to be used in and the facilities or controls to be used for the manufacturing, processing, packing or holding a drug to assure the drug meets the safety, requirements of the Federal Food Drug and Cosmetic Act and that the drug has the identity, strength, and quality and purity characteristics it is represented to possess.
The agency's risk and science based approaches under the CGMP initiative are aimed at ensuring that regulatory review, compliance and inspection policies are based on state-of-the-art pharmaceutical science, and do not impede rapid adoption of new technological advances by the pharmaceutical industry.