April 2007 - Pharmaceutical Technology

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April 2007

Pharmaceutical Technology


WARNING LETTER

FDA Issues Warning Letter to Bell-More Laboratories




Rockville, MD (Jan. 5)—The US Food and Drug Administration ( http://www.fda.gov/) issued a Warning Letter to Bell-More Laboratories (Hampstead, MD, http://www.bell-more.com/) following the agency's August 2006 inspection of the company's Hampstead pharmaceutical facility. During the inspection, the agency documented deviations from current good manufacturing practices that caused Bell-More's finished products to be adulterated. The agency asserted that Bell-More's inadequate controls and documentation create the potential for the migration of potent compounds throughout the facility.


Company Notes
The deviations enumerated in the letter include the failure to establish defined areas or other control systems to prevent contamination or mixups for handling and manufacturing potent compounds (21 CFR 211.42[c]); the failure to keep records for the maintenance, cleaning, and sanitizing of equipment (21 CFR 211.67[c]); the failure to adequately validate cleaning procedures for manufacturing and packaging equipment (21 CFR 211.67[a]); the failure to establish and follow procedures to prevent microbiological contamination (21 CFR 211.113[b]); the failure to establish written procedures for production and process control designed to ensure drug product identity, strength, quality, and purity (21 CFR 211.100[a]); and the failure to establish sampling plans, test procedures, and laboratory control mechanisms for testing the finished-product sterile evacuated vials (21 CFR 211.160[a]).

Bell-More Laboratories is a contract pharmaceutical manufacturer specializing in the custom lyophilization of small-volume parenteral drugs in vials and syringes.
-Erik Greb

WARNING LETTERS

Warning Letters Demand Stop to Unapproved Ergotamine Manufacture and Distribution

Rockville, MD (Mar. 1)—Sending Warning Letters to eight manufacturers and 12 distributors, the US Food and Drug Administration ( http://www.fda.gov/) ordered a stop to the manufacture and distribution of unapproved drug products containing ergotamine tartrate. The action does not affect FDA-approved products containing ergotamine. Most of the companies receiving the letters have omitted from their drugs' labeling a critical warning regarding the potential for "serious, possibly fatal, interactions with certain other drugs," including potent CYP 3A4 inhibitors, according to the agency.

"Unapproved drugs pose real risks to the American public," said Steven Galson, MD, director of FDA's Center for Drug Evaluation and Research, in a public statement. "It is central to our mission to ensure a safe and effective drug supply for the American public."

FDA estimates that less than 2% of prescribed drugs on the market are unapproved and continues to combat the marketing of unapproved drugs through its Unapproved Drugs Initiative.


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