Macco Organiques – FDA Warning Letter, Apr 23, 2010

An FDA inspection of Macco Organiques, Inc.'s API manufacturing facility in Canada from April 20-23, 2010, revealed significant Current Good Manufacturing Practice (CGMP) deviations, rendering their APIs adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The firm's response of April 30, 2010, was deemed insufficient. Key violations included inadequate laboratory controls and record maintenance, such as discarding original raw data and deficient analytical notebooks. The quality unit failed to ensure CGMP compliance, evidenced by inadequate investigation of production deviations, including releasing a batch with black particles. Repeat observations highlighted the quality unit's failure to perform process validation, stability studies, and cleaning validation for USP products. Facility deficiencies included live insects in raw material bags, dust, and debris, indicating poor design and maintenance. Additionally, the firm failed to register and list all APIs in commercial distribution in the U.S., as required by 21 C.F.R. § 207.40 and section 510(i) of the Act. The FDA emphasized that removing "USP" from labels does not negate compendial compliance. The Agency noted that many repeat deviations stemmed from poor supervision and lack of quality assurance oversight. Macco Organiques must provide a written response within fifteen working days detailing corrective actions, recurrence prevention, and supporting documentation, including completing registration and listing. Failure to comply may result in the withholding of new application approvals and refusal of admission of articles into the U.S.