FDA Issues Warning Letter to Bell-More Laboratories

Rockville, MD (Jan. 5)-The US Food and Drug Administration (www.fda.gov) issued a Warning Letter to Bell-More Laboratories (Hampstead, MD, 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 CGMP regulations in 21 CFR Parts 210 and 211 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.

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; the failure to keep records for the maintenance, cleaning, and sanitizing of equipment; the failure to adequately validate cleaning procedures for manufacturing and packaging equipment; the failure to establish and follow procedures to prevent microbiological contamination; the failure to establish procedures to ensure drug identity, strength, quality, and purity; and the failure to establish testing procedures for finished product.

Bell-More Laboratories is a contract pharmaceutical manufacturer specializing in the custom lyophilization of small-volume parenteral drugs in vials and syringes. For the full text of the Warning Letter, click here.