Microbiology FDA 483 : Laboratory records are not completed & contemporaneously to assure compliance with specifications
Observation
Facility Type
Firm / Company
Sichuan Deebio Pharmaceutical Co. Ltd.
System
Details
During our visit to QC microbiology laboratory, we observed that microbiology TAMC test results for QC microbiology work bench (*plates) and biosafety cabinet (*plate), *** water samples from Workshop *** plates, sample points *** USP drug substance production for US Market), and *** samples from workshop *** plates sample points *** domestic and non US international market production), and workshop *** plates, sample points *** (domestic and non US international market production) purported to be read by your QC team leader, had not been recorded per your firm’s SOP no. MA***-**, titled ‘Data reliability management procedures’, effective date **/**/2021.
Specifically, upon entering the microbiology laboratory **/**/2023 at approximately 11:40 am, we observed approximately *** plates in the waste bin which had been *** Per your QC team leader, she stated that she had read these plates earlier in the morning around 10:00 am, and the test worksheet with recorded results was downstairs with a QA personnel.
Your QC team leader than proceeded to provide misleading information, stating that she did not read the results as she had stated doing so when we first arrived in the laboratory, and shortly after this stated that she did read the results and signed the test data worksheet which was somewhere on the *** floor with QA personnel, only to finally admit that she did in fact read the plates, however, was not telling the truth about recording the results on respective data worksheets, and no worksheet existed. When we asked the analyst how she remembered the results of all *** plates, she stated that it was in her “‘mind” and proceeded to provide at least *** plate results varying from 18 to 23 CFU from “memory’.
Your firm’s investigation was not able to replicate any of these 12 values that your analyst provided to us in person. We left the laboratory around 1:40 pm, having initially arrived around 11:40 am. As a result of providing misleading information with respect to these samples, your firm delayed our inspection.
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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.