Microbiology FDA 483 (Alkem Laboratories): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards,  test procedures

Observation

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, chug products conform to appropriate standards of identity, strength, quality and purity

Facility Type

Non-Sterile Manufacturing

Firm / Company

Alkem Laboratories Limited

System

Quality System, Laboratory Controls, Facility and Equipment System

Details

Specifically,

The microbiology worksheets do not document the incubation staff and end times for media/samples in all steps required testing. For example,

  • The Microbial Limit Testing performed on *** Tablets Batch *** on long term stability conditions at time point 35 months requires Incubation of the *** Medium at 30-35°C for *** and incubation at 30-35°C for ***. The documented dates are ***. There is no indication the incubation time met the first *** requirement.
  • The Test for Specified Microorganism performed on *** sampling point SPQ/*** sample *** requires the inoculated *** Medium to be incubated at 30-35°C for ***. The worksheet indicates the analysis was performed 22 MAR 2024 and the observation was verified on 23 MAR 2024. There is no indication the incubation time met the *** requirement.

Record Date

04/2024

FEI Number

3006370533

Country

India

Citation Type

483

Audit Duration (Days)

7

Investigators

Nicole E. Knowlton, Yvins Dezan
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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