1Deviation, CAPA, and investigation
Failure to ensur~ all production deviations are reported and evaluated, and that critical deviations are investigated and the conclusions are recorded.
Inspection Record
Cipla Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment qualification procedures are not foilowed Specifically, OATE{S} OF INSPECTION 3/28/2024 - 4/4/2024 Patalganga Industrial Area, Plot No A-2, A-33, A-37/2/2, A-42 Human and animal APl and human drug product manufacturer (6rC4> Your firm did not follow procedure 103i5-=-°.J).Q.42 - Qualification ofEquipmentr-for;...t.;...el!:::::===-=~ ~ h__ 4 Your firm acquired and began using th,;,: tliR 4m2023 forJ <6>c pSP:-a-c-:-t1.-v_e___.
3Deviation, CAPA, and investigation
Failure to adequately investigate out-of-specification results Specifically, Since Ma 2020, rour firm has documented 8 OOS investigations related to particle size distribution (PSD) for the <tim>USP t· h • • · • ac 1ve p annaceut1cal mgred,ent (API) manufactured at Unit- ( o include O<?S-10 °=202±,Q2B} 3.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
About this record
Extracted automatically from the document US FDA published on 2024-04-10. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
