Zhejiang Tianyu Pharmaceutical Co., Ltd.
6 extracted findings
FDA source excerpt, selected passage
Failure to extend investigations to other batches that may have been associated with a specific failure or deviation.
FDA published a close-out letter on Mar 11, 2025. The findings below are from the original warning letter.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure to extend investigations to other batches that may have been associated with a specific failure or deviation.
Source passage selected by the model
02
Failure to establish an impurity profile for identified and unidentified impurities.
Source passage selected by the model
03
Your firm failed to conduct a comprehensive evaluation of the manufacturing process to identify all potential impurities.
Source passage selected by the model
04
Failure to clean equipment at appropriate intervals to prevent build-up and carryover of contaminates and degradants where equipment is assigned to continuous production or campaign production of successive batches of the same intermediates and API.
Source passage selected by the model
05
Your firm failed to complete cleaning validation studies prior to release and distribution of **(b)(4)** batches of **(b)(4)** starting material from 2020 to 2022. You acknowledged your cleaning validation was not completed before the batches were distributed. Although the **(b)(4)** is manufactured on dedicated equipment trains, there was no assurance your cleaning methods were adequate and that no contamination was carried over from batch to batch during production campaigns.
Source passage selected by the model
06
Failure to address deviations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any deviations.
Source passage selected by the model