Microbiology FDA 483 (Dr. Reddy’s Laboratories): Failed to establish and/or follow adequate written gowning procedures
Observation
Facility Type
Firm / Company
Dr. Reddy's Laboratories Ltd.
System
Details
Specifically, your firm failed to establish and/or follow adequate written gowning procedures pertaining to the core manufacturing areas to ensure the drug products have the identity, strength, purity, and quality that they represent to possess. For example:
(A) On 10/19/2023, during the inspection of *** area (Room #***), Operator *** was observed with a hole in ***shoe. This room *** major production equipment including *** (equipment ID: PRE-1615), *** equipment ID: 1649), and *** (equipment ID: 1650). On 10/*** *** being used to manufacture *** Caplet *** mg batch *** for the US market). The firm’s SOP-FT030005, “Cleaning of Primary and Secondary Footwear” requires the firm provided footwear be inspected for damages before being washed at the ***. This SOP further states, “Damaged shoes shall be sent for disposal“. In this case the firm failed to follow its procedure.
(B) The firm’s employees’ have deviated from SOP No.: SOP-FT03-PR00235, Version: 3.0, section 6 – Primary Gowning pertaining to beard mask. On 19-0ct 2023, Observed beard mask were not available for employees entering inside the manufacturing suits. As such, most of the employees working in production areas had exposed beard due to inadequate head cover and not wearing beard covers. Further, the pictorial images for ent1Y and exit posted in the firm’s gowning areas does not indicate the need for wearing a beard mask (if necessary).
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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.