FDA EIR - Specialty Minerals, Inc. - August 22, 2019

An FDA surveillance inspection of Specialty Minerals, Inc. in Adams, MA, conducted from August 19-22, 2019, focused on Good Manufacturing Practice (GMP) compliance for their Active Pharmaceutical Ingredient, Calcium Carbonate USP. The inspection, carried out under established FDA guidance for API and drug manufacturing, identified three significant deficiencies, which were detailed in an FDA-483 observation report. Key violations included incomplete laboratory control records. Specifically, critical data such as sample weights, reagent information, and personnel signatures were absent for elemental testing and solution standardization, compromising data integrity. Secondly, the firm's quality system exhibited a recurring failure to complete customer complaint investigations within the prescribed 30-day timeframe, a repeat observation from a previous 2015 inspection. Lastly, an investigation into a customer's microbial contamination complaint for Calcium Carbonate USP was found inadequate. The company initially overlooked the issue, mistakenly asserting no microbial testing requirement, and failed to adequately assess the contamination source. Additionally, the firm lacked a procedure for handling out-of-trend microbial test results and did not have established limits for microbial enumeration tests. Company management, led by Plant Manager Steven C. Thompson, acknowledged the findings. Mr. Thompson committed to submitting a written response within 15 business days. Quality Assurance Manager Anh Nguyen pledged to correct the laboratory record deficiencies and reopen the microbial complaint for thorough investigation. Other discussions involved updating National Drug Code listings and incorporating microbial trending data into Annual Product Reviews.