Compounders Slapped With Warning Letters for Misbranding, Sterility Problems

Two compounding operations are facing FDA allegations for producing adulterated drugs following agency inspections.

One warning letter dated March 23 accused Winchester, Va.-based Wellness Pharmacy of improperly compounding without individual patient prescriptions, misbranding and adulteration.  Another compounding pharmacy — Custom Compounding Center in Little Rock, Ark. — was accused of the same violations plus the production of unapproved drugs.

The FDA’s Baltimore District Office accused Wellness Pharmacy of “serious deficiencies” in its production of sterile products. The letter was prompted by an inspection in March 2015.

Custom Compounding’s citation included complaints coming from the agency’s Dallas District office. The March 16 letter cited the company for “serious deficiencies” with its sterile compound production.