Warning Letter: Southern Meds

February 24, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Warning Letter: Southern Meds

On Feb. 15, the US Food and Drug Administration's  New Orleans’ District Office (New Orleans, LA, www.fda.gov) posted a Warning Letter to Southern Meds (Biloxi, MS), a compounding pharmacy.

The warning cited the firm for misbranding their compounded drugs, interstate commerce violations and lapses in current good manufacturing practice (CGMP) in the production of sterile injectable drug products, including estradiol valerate, methylprednisolone acetate, and dexamethasone acetate.

The cited CGMP deficiencies included: lack of appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, not have control systems to prevent contamination, failure to test each batch of drug product purporting to be sterile by appropriate laboratory determination of satisfactory conformance to final specifications, and distributing twelve lots of prescription injectable drug products even though these drug products failed to meet the established USP standards.

FDA's warning letter indicated that the company should take prompt action to correct all of the violations noted in the letter, and should establish procedures so that such violations do not recur.