FDA EIR - Sterling Pharmaceutical Services LLC - April 06, 2018

An FDA inspection of Sterling Pharmaceutical Services, LLC, located in East Carondelet, IL, was conducted from March 22, 2018, and April 2-6, 2018. This initial comprehensive inspection, covering human and animal prescription drug manufacturing, was carried out under Compliance Programs 7356.002 and 7371.001.

At the inspection's conclusion, a 5-item FDA Form 483, Inspectional Observations, was issued to President Robert G. Flynn. Main violations included a lack of adequate production and process controls, specifically insufficient process validation, and a lack of scientifically sound laboratory controls concerning test procedures and sampling plans. Further issues noted were deficient complaint procedures, an inadequate retain sample program, and a failure to record deviations from written production and process control procedures. Verbal observations also highlighted the absence of essential Standard Operating Procedures for data integrity controls and the handling of chemically/heat-treated pallets, as well as a lack of defined trending for Out-of-Specification and Out-of-Trend results.

Management was reminded of their responsibilities to adhere to the Food Drug and Cosmetic Act and the potential consequences for non-compliance, indicating a requirement to address these significant deficiencies to achieve regulatory compliance.