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Talk to a SpecialistTalk to a SpecialistDr Retter Ec Wladyslaw Retter, a Polish manufacturer of over-the-counter drug products, violated current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The company failed to establish adequate written procedures for production and process control and distributed a homeopathic cream to the United States without proper process validation data, with the active ingredient concentration not matching the labeled potency specification. The facility's methods, facilities, and controls for manufacturing, processing, packing, and holding did not conform to CGMP requirements under 21 CFR parts 210 and 211.