FDA EIR - Alcami Corporation - March 19, 2018

An FDA inspection of Alcami Corporation, an Edison, NJ-based control testing laboratory, occurred from March 9 to March 19, 2018. Conducted under the PHRM1 FY’18 Drug Work plan and CPMG 7356.002 (Drug Manufacturing Inspections), the inspection evaluated the company’s Quality, Facility and Equipment, and Laboratory Control Systems. The inspection yielded an FDA Form 483 detailing three key violations. First, the Quality Control Unit failed to fully follow its procedures by not completing data review verification for specific projects before releasing certificates of analysis, a breach of 21 CFR 211.22(d). Second, laboratory controls were inadequate, with numerous samples not properly logged into the electronic system, and the sample handling SOP (SOP69302.08) lacking sufficient detail for accurate tracking and traceability. Third, laboratory records were deficient, as raw data from certain tests (USP <81>) was not fully captured or adequately protected from modification or deletion, posing a risk of altering failing results, referencing 21 CFR 211.194(a)(4). A verbal observation also highlighted inadequate facility maintenance, specifically an unaddressed recurring roof leak in the chemical laboratory with only temporary repairs. Alcami management acknowledged these deficiencies and committed to submitting written responses within 15 business days. Corrective actions initiated included a deviation investigation and a draft SOP update for sample handling, and updated test procedures with a CAPA for data integrity issues. Management also agreed to address the facility maintenance concerns.