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Complaint and Deviation Handling, Contamination Control Continue to Draw FDA Attention at Vaccine Plants

Jul 31st, 2010

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Complaint and deviation handling/reporting and contamination control – concerns that have been in the forefront of FDA attention during vaccine manufacturing inspections – were again focal points at a March/April inspection of Sanofi Pasteur’s vaccine plant in Marcy l’Etoile, France that resulted in an “untitled letter” from the agency on July 22.

FDA’s focus on vaccine production has escalated in recent years as this product segment has expanded.  This focus was reflected in warning letters during 2008 to two major vaccine manufacturers, Merck and Novartis (IPQ May/June 2009 Report), citing some of the same concerns found at Sanofi.  The letters are as much indicative of the complexity of the operations involved as the level of GMP non-compliance.

The untitled letter to Sanofi maintains that inspectors found “significant deviations” from CGMP requirements in the firm’s manufacture of both licensed biological products and bulk drug substances. The warning letters to Merck and Novartis also referenced both bulk and dosage production facets.

Vaccines involved in the Sanofi inspection included the rabies vaccines Imovax and Imogam, Act-HIB (Haemophilus influenzae), Ipol (polio), and Typhim Vi (typhoid). A rabies vaccine was also among the products implicated at Merck and a hemophilia vaccine at Novartis.

In the Sanofi letter, FDA acknowledged receipt of the firm’s written responses to the 483 inspection observations, dated April 21, May 17 and June 11.  However, the agency requested further response to specific items and a commitment that the responses will be addressed globally.

(Further analysis of FDA’s findings at Sanofi and comparison with the Merck and Novartis warning letters is provided for subscribers on page 2.)

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