Microbiology FDA 483 (Zydus Lifesciences): Buildings used in the manufacturing of a drug product are not maintained in a good state of repair

Observation

Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair

Facility Type

Sterile Manufacturing

Firm / Company

Zydus Lifesciences Limited

System

Quality System, Laboratory Controls, Facility and Equipment System

Details

Specifically,

(A) On 3/20/2024, we inspected the HVAC mechanical space and *** the aseptic filling line *** ceiling. The roof of the building that covers this area was noted to have multiple holes and visible light to the exterior of the building.

(B) On 3/20/2024, we inspected the QC microbiology storage room *** (controlled non-classified, CNC) and noted what appeared to be mold on and around the air vent in the ceiling of the room. Your firm stores various QC microbiology supplies in room to include testing canisters for drug product sterility and environmental monitoring plates utilized for aseptic filling line ***.

(C) Various areas within your facility were observed to have what appeared to be water stained ceilings indicative of prior water leakage events to include:

  • *** CNC hallway leading into line *** production area.
  • *** Laboratory change room.
  • *** Corridor between retain storage room and material storage room. –
  • *** Drug product retain storage room.

Record Date

04/2024

FEI Number

3007621329

Country

India

Citation Type

483

Audit Duration (Days)

7

Investigators

Sean R Marcsisin, Lori M Newman

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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.

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