FDA warns Jubilant HollisterStier about cGMP violations
Identifies a number of procedural failings and water in the aseptic filling area
The US Food and Drug Administration (FDA) has sent Jubilant HollisterStier, the sterile fill/finish and semi solid pharmaceutical contract arm of Jubilant Life Sciences, a warning letter following an inspection last March that revealed cGMP violations at its facility in Kirkland, Quebec, Canada.
The FDA said in the letter that it had identified a number of failings, including not investigating rejected batches properly or implementing any preventative actions in a ‘timely manner to prevent recurrence of manufacturing deviations’. Nor did the company have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to the final specification, including the strength of each active ingredient, prior to release, the FDA said.
In addition, Jubilant had released products that did not meet the visual inspection specification for major defects, and after a compression failure following a power cut resulted in a 34ºC increase in temperature, although more than 2,500 vials were inspected out of the batch, the company allowed the remainder to be released.
The FDA asked Jubilant to explain this response, and include ‘details of whether it is feasible for the company’s operators to visually detect and sort out all affected units of a batch following such a significant temperature deviation’.
The inspectors also noted that Jubilant failed to establish adequate written procedures for production and process control to assure that the drug products it manufactures have the ‘identity, strength, quality or purity’ they purport to possess. The company did not provide for a second inspection or additional evaluation when a product fails to meet its specification, the FDA said.
The inspectors also noted water on the floor of the equipment washroom that was tracked into the dirty equipment staging room then into the pharmaceutical corridor leading to the sterile production hallway, the production line and the vial filling area.
The FDA asked Jubilant to provide details of the measures taken to ensure that water from other areas is not introduced into the aseptic filling area.