Measurement Specialties, Inc. – FDA Warning Letter, Jul 25, 2011

The FDA issued a Warning Letter to Measurement Specialties, Inc. following a May-July 2011 inspection, identifying their temperature probes as adulterated medical devices under 21 U.S.C. § 351(h). The firm's manufacturing methods and controls failed to conform to the Quality System (QS) regulation, 21 CFR Part 820. Significant violations included: inadequate corrective and preventive action (CAPA) procedures lacking statistical analysis (21 CFR § 820.100(a)(1)); insufficient control of nonconforming product, leading to improper handling and packaging (21 CFR § 820.90(a)); failure to establish and follow rework procedures (21 CFR § 820.90(b)(2)); absence of procedures for valid statistical techniques in process control (21 CFR § 820.250); unverified or unvalidated changes to manufacturing processes (21 CFR § 820.70(b)); inadequate incoming product acceptance procedures (21 CFR § 820.80(b)); failure to identify training needs and ensure personnel competency, including the Quality/Regulatory Manager (21 CFR § 820.25(b)); and quality audits conducted by individuals with direct responsibility for audited areas (21 CFR § 820.22). The FDA found many of the firm's proposed corrective actions unassessable, demanding submission of revised procedures and documentation of completion or status updates within fifteen working days. Failure to promptly correct these systemic QS deficiencies could result in severe regulatory actions, including seizure, injunction, civil money penalties, and negative impacts on federal contracts, premarket applications, and Certificates to Foreign Governments.