Becton Dickinson Caribe LTD – FDA EIR, Jul 29, 2021

An abbreviated FDA inspection of Becton Dickinson Caribe LTD (BD IDS Cayey), a manufacturer of Class I and II in-vitro diagnostics (IVD) products, took place in Cayey, PR, from July 20 to July 29, 2021. The inspection was conducted under Compliance Program-7382.845, the regulatory framework for medical device manufacturers, specifically evaluating the firm's Corrective and Preventive Actions (CAPA) and Production and Process Controls (P&PC) systems.

Significantly, the inspection identified no objectionable conditions. As a result, no Form FDA 483 (Inspectional Observations) was issued, and no discussion items were sustained, indicating full compliance during the review period. The company maintains a current FDA registration. Investigators found no deficiencies during their assessment of the firm's CAPA system, which included reviewing internal audits, deviations, complaints, and supplier processes. Likewise, the evaluation of Production and Process Controls for manufactured IVD products such as Bactec and SensiDisc revealed no shortcomings. The company's procedures for product corrections, removals, and complaint handling were reviewed and deemed adequate, with divisional units managing final determinations and initial complaint processing. Given the absence of identified issues, no specific actions were required from Becton Dickinson Caribe LTD following this inspection, though the Agency always encourages voluntary compliance.