According to the warning letter released this week, Quebec, Canada-based Jubilant HollisterStier, a subsidiary of India-based Jubilant Life Sciences, failed to:
- Conform to final specifications for the drug product, including identity and strength of each active ingredient prior to their release;
- Establish acceptance criteria for the sampling and testing to assure drug batches meet each appropriate specification and appropriate statistical quality control criteria; and
- Establish adequate written procedures for production and process controls.
FDA inspectors in March 2012 also “noted water running on the floor of the equipment wash room that was tracked into the dirty equipment staging room and further, into the pharmaceutical corridor leading to the sterile production hallway” and the vial filling area. Jubilant must provide an explanation on how it will assure that its facility will not allow water to be introduced into the aseptic filling area, according to the letter.
In addition, Jubilant failed to perform an investigation after one lot of an injection failed to meet in-process pH requirements and did not provide information on the actual root cause for the failure to meet the in-process limits.
A compressor failure due to a power outage at the facility also resulted in temperature deviations that lead to the “unacceptable appearance” of more than 2500 vials of injections. But Jubilant “allowed the remainder of the batch to be released,” and the FDA would like the company to explain this decision.
The agency also calls on the company to provide “updated information on all CAPAs [corrective and preventive actions] related to manufacturing operations and quality control” initiated since March 1, 2012, as well as a “brief summary explaining whether your delay in implementing timely CAPAs to resolve root causes of problems affected the quality of the released product.”
Jubilant has until March 15 to respond to the FDA’s questions and cited violations.