The United States Food and Drug Administration (USFDA) has conducted an un-announced in-person inspection of Jeevan Scientific Technology’s (JSTL) clinical pharmacology centre facility and a remote record review of the company’s bioanalytical facility.
The purpose of the inspection/review was to audit the BA/BE studies as well as the operations, systems and procedures. At clinical pharmacology centre facility, the auditor(s) started the inspection on May 31, 2022 and closed on June 10, 2022, with an issue of a Form 483. For the bioanalytical facility, the remote review started on June 09, 2022 and was closed on June 16, 2022 with no significant objectionable observations.
The observations are related to procedural improvements and the company has addressed most of them with required evidence(s) during closeout(s). Also, the outcome of the audit(s) is not restrictive in nature and do not hinder the smooth operations of both facilities. Further, JSTL team is comprehensively working on closing the observations within stipulated timelines.
Jeevan Scientific Technology carries business clinical research and data management services.
