FDA EIR - Microbiological Testing & Consulting LLC - March 08, 2018

An FDA follow-up inspection of Microbiological Testing & Consulting, LLC, a contract testing laboratory for over-the-counter (OTC) drug products and cosmetics, was conducted from March 5-8, 2018. This inspection, performed under Compliance Program 7356.002 for Drug Manufacturing Inspections, uncovered five significant deficiencies, many of which were repeat observations from a previous 2016 inspection.Key violations cited in the FDA 483 included inadequate growth promotion testing for media, insufficient method suitability studies for drug products, and failure to ensure proper neutralization of antimicrobial substances. The firm also demonstrated inadequate equipment qualification and a lack of periodic calibration for measurement equipment. Furthermore, the quality unit’s responsibilities and procedures were found to be either unwritten or not fully followed, encompassing issues like the absence of a change control system and flawed out-of-specification (OOS) procedures.Additional verbally discussed issues included lapsed FDA registration, absence of quality agreements with clients, and consultants lacking pharmaceutical cGMP expertise. The regulatory framework for this inspection primarily involved 21 CFR Parts 210 and 211 and USP Chapters <61> and <62>.The company is required to submit a written response to the FDA 483 within 15 business days, addressing all cited deficiencies, particularly the repeat observations. This entails implementing robust growth promotion and method suitability testing, ensuring proper equipment qualification and calibration, establishing comprehensive documentation practices, and strengthening the overall quality system, including re-registration and addressing consultant qualifications.