FDA EIR - Precision Dose Inc. - January 28, 2019

An FDA inspection of Precision Dose Inc., a unit dose repackaging facility in South Beloit, IL, was conducted from January 14-28, 2019. The inspection, carried out under Compliance Programs for Drug Manufacturing and Repackagers and Relabelers, aimed to ensure the firm's adherence to regulatory standards for human prescription and over-the-counter drug products. The inspection resulted in the issuance of an FDA Form 483 with two main observations. Firstly, Precision Dose Inc. was cited for failing to consistently follow its established written procedures. This included inadequacies in reporting historical complaint data during investigations and the lack of proper review or extension for an expired temporary change order. Secondly, the firm's complaint investigations were found to be insufficient; they either failed to cover all reported issues, such as neglecting to investigate potential shipping damage for leaking products, or were not thoroughly conducted. Additional concerns discussed with management included missing identification numbers for critical equipment on batch records, minor documentation errors, and employee practices in staging areas that posed a risk of particulate contamination to drug products. Inconsistent storage of cleaned totes was also noted. Precision Dose Inc.'s management acknowledged these observations and committed to submitting a formal response to the FDA's Chicago District Compliance Branch within fifteen business days, outlining their planned corrective actions to address the identified deficiencies.