Maison Terre, LLC — FDA Warning Letter Findings

Other CGMP Noncompliance Your affidavit also demonstrated that your facility was not in compliance with other applicable CGMP requirements including the following: You failed to establish and follow written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You failed to establish and follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)). You did not keep…

Your firm failed to conduct appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(b). You did not conduct any testing on the drug product you repackaged and sold for microbial attributes, including absence of objectionable microorganisms, or sterility, where appropriate. We note that the statements on your website claim that “Goldenseal Root Powder Organic” is intended for use as an “antiseptic skin bath for wounds and for internal skin surfaces.” As a drug product that is intended for use as a topical antiseptic on broken skin, it is essential that your drug products are tested for microbial contamination. Because wound site tissues are injured or diseased, they are more susceptible to infection.

Your firm failed to test before use each lot of a component, drug product container, or closure with potential for microbiological contamination that is objectionable in view of its intended use (21 CFR 211.84(d)(6)). FDA identified similar levels and types of objectionable microcontamination as those found in your “Goldenseal Root Powder Organic” drug product in the bulk goldenseal root powder material you received from your supplier. As a finished drug product manufacturer, you are responsible for implementing management oversight and controls to ensure quality and safety of all materials used in manufacturing. Your firm failed to prevent use of incoming material lots that contained objectionable microbial contamination. Instead, you repacked and distributed the hazardous product to your customers.

Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). The gross level and types of micro-contamination in drug product manufactured in your facility also demonstrate that the quality assurance within your facility was not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the Act and FDA's regulations at 21 CFR Parts 210 and 211. In addition, the practices you described in your affidavit, as set forth in more detail below, were consistent with an establishment that lacked an adequate quality unit to oversee the adequacy of your repacking operations and assure finished product quality (21 CFR 211.22).

Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups. (21 CFR 211.42(c)). You sold various other products (e.g., herbs, oils, and spices) in addition to “Goldenseal Root Powder Organic,” yet you failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)). Photographs and an affidavit you provided to our investigators showed…