Microbiology FDA 483 (Kilitch Healthcare) : Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures
Observation
Facility Type
Firm / Company
Kilitch Healthcare India Limited
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Details
(1) Environmental monitoring and personnel monitoring data is not reliable because of the materials used to conduct tests.
(a) *** contact plates prepared in house did not have enough media to ensure the *** surface was above the rim all the way around the plate on 27 of *** plates observed on October 12, 2023. At the end of incubation, 8 of the *** plates showed desiccation of the media.
(b) Settle plates that had been exposed in the aseptic manufacturing were observed to have media that was desiccated and cracking.
(c) In house-prepared environmental monitoring media does not contain neutralizers. Spray disinfectants are used in the areas where monitoring occurs. On October 19, 2023, *** was sprayed directly over settle plates during the setup for batch ***.
(2) During sterility testing of sterile components by direct inoculation, the components were not observed to be completely submerged in the media.
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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.