Microbiology FDA 483 (Dr. Reddy’s Laboratories): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination
Observation
Facility Type
Firm / Company
Dr. Reddy's Laboratories Ltd.
System
Details
Specifically, major production equipment used to manufacture *** dosage drug products is not appropriately cleaned and maintained to prevent contamination. For example:
The *** non-dedicated *** used in the manufacturing of finished drug products at the firm have not been cleaned and verified for cleanliness underneath the mounted platform areas since their installation several years ago. There is a potential for deposition of *** materials and microbial growth in these areas in all *** across the facility.
On 20-0ct-2023, observed *** deposition and layers of *** materials underneath the mounted platform of *** ID: PRE-078. This *** mounted platform has about *** through which *** residues of drug products manufactured in this room *** may have deposited throughout the machine components of this *** over the period of several years due to positive air pressure inside the room. Along with the *** materials, observed the surface underneath *** platform had *** liquid and wet surface across many areas which is indicative of potential microbial growth in those areas of ***. The swab samples were collected from these areas which revealed the presence of fungal growth on mounted platform surface underneath *** ID: PRE-078.
There are *** drug products manufactured in *** area of which about *** are sold into the US market.
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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.