Microbiology FDA 483 (Precision Equine LLC): Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination

Observation

Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product

Facility Type

Sterile & Non-Sterile Manufacturing

Firm / Company

Precision Equine LLC

System

Details

During walk-through of the facility on 8/23/2023, contamination was observed in your sterile and non-sterile areas for the following:

  • Unknown yellow stains were observed on HEPA filters inside the ISO 5 LAFH used for producing sterile non-hazardous animal drug products in the Sterile Non-Hazardous Drug Suite.
  • The frame of the HEPA filter inside the LAFH peeled off in the Sterile Non-Hazardous Drug Suite.
  • Many white stains were observed on scales and walls of *** hoods *** used for producing non-hazardous drug products.
  • Unknown stains were observed on a scale inside the *** hood used for compounding of sterile hazardous in the Sterile Hazardous Drug Suite.
  • Unknown powders/residues were observed on a scale inside *** Hood *** used for producing non-sterile while the hood was not in use on that day.
  • Opened drink cans and drink cups with visible liquid and spoons were discarded in trash bins in the non-sterile production area.
  • A filter used to filter supply air inside the wall of the ISO 7 Negative Pressure Clean Room next to the ISO 5 BSC looked dirty with apparently visible debris in Sterile Hazardous Drug Suite.

Record Date

01/2024

FEI Number

3005698544

Country

California

Citation Type

483

Audit Duration (Days)

9

Investigators

Taichun Qin, Sara H Gabel, Julia N. Alvarez
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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