Microbiology FDA 483 (Kilitch Healthcare): Failure to thoroughly review any unexplained discrepancy
Observation
Facility Type
Firm / Company
Kilitch Healthcare India Limited
System
Details
Your firm failed to adequately assess the following complaint batches for potential microbial contamination.
(1) Complaint investigation 05/23, received May 9,2023, for ***, ***, *** Batch#***, (US Market), was initiated for *** have growth inside”.
(2) Complaint Investigation 04/23, received April 15, 2023, for *** *** Batch#***, (US Market), was initiated for “burning *** and oozing”.
(3) Complaint Investigation 01/22 received, July 22, 2022, for *** *** Batch#***, (US Market), was initiated for “burning, *** “noticed ***.
Record Date
FEI Number
Country
Citation Type
Audit Duration (Days)
Investigators
More observations from same firm / company
FDA 483 relevant to Microbiology
Disclaimer: The purpose of this article is to provide helpful information on FDA 483s related to microbiological issues. This article represents 483 information in Tabular form for quick access and easy navigation. Information for this article is derived from “Form FDA 483” (Inspectional Observation). This article is not intended to replace the information provided by the FDA, nor is it guaranteed to be complete, always refer official FDA site for details.