Missing Investigation of OOS Results leads to FDA Warning Letter

Recommendation

24/25 April 2024

QC Compliance Manager - Live Online Training

FDA's Warning Letter issued to the Indian API manufacturer Keshava Organics Pvt.Ltd dated 15 March 2018 was issued as a consequence of a FDA inspection performed in May 2017. The FDA particularly criticized the insufficient investigation of diverging analysis results.

Several times, the company re-tested original analysis results which didn't comply with the specifications, without having first performed a Phase 1 laboratory investigation to support invalidation of the result. Likewise, manifold, Phase 2 of the investigation hadn't been carried out to evaluate the production area which may have brought potential root causes for the deviations.

The company's response contained a retrospective review of OOS results. Here, OOS results were defined as deviations ("incidents") and not as OOS results - as would have been correct. No OOS investigations were performed for those incidents. Thus, it was impossible to provide reliable information and scientific evidence with regard to possible wrong hypotheses in the lab.

Furthermore, in multiple instances, data for the investigation of APIs weren't complete. The FDA discovered analysis data sheets with missing sample weights for identity testing as well as missing batch numbers for reference standards and reagents. Regarding the identification of equipment, not all the data were complete like, for example, thin layer chromatography data for related compounds.

Please also see the FDA Warning Letter to Keshava Organics Pvt. Ltd. for further information.