FIRM FALSIFIES MICROBIAL DATA
Canton Laboratories, India was found to have reported analytical results without having performed the testing. C of A’s stated that the data conformed to specifications; however, multiple personnel confirmed that the testing was not performed. Similar data was observed in July 2008 with other testing. Please read below to learn more about another Indian example of data falsification and adulteration.
1. Failure to perform laboratory testing of APIs to ensure conformance to specifications and to accurately report results on Certificates of Analysis (CoA).
Your firm reported microbial limits results on CoAs for three API batches without performing these tests. Specifically, your firm has no raw data for the microbial limits tests reported on the CoAs for (b)(4) USP lots (b)(4), and (b)(4). Your quality unit approved the release of these API batches without data to support that release specifications were met. While your CoAs state that microbial limits conformed to specifications, the inspection found that no testing was done. Multiple personnel confirmed that your firm did not perform the microbial tests reported on the CoAs.
Similarly, our inspection found other examples where your firm did not have raw data, yet reported testing as acceptable on your CoAs. For example, your firm released (b)(4) USP (for use in (b)(4)) and (b)(4) USP (for use in (b)(4)) without supporting documentation for metallic impurities testing.
Your firm’s response to this observation stated that your firm has revised relevant SOPs and performed training on these SOPs. We note that the previous inspection in July 2008 found a similar observation. That inspection found that your firm did not retain raw data and documentation for Karl Fischer titration, Assay, Specific Gravity, solubility, clarity, and pH of (b)(4), USP. Your firm’s response to the 2008 observation, similar to your response to the current findings, was to correct this issue through retraining and document revision. It is very concerning that your firm has not taken the proper actions to address the underlying issues.
In your response, provide a complete corrective action plan that begins with a retrospective review of the analytical data and batch records for all products that remain within expiration. It is essential that this investigation includes all products manufactured at your site. In addition, provide details of the systemic actions taken to prevent recurrence of these fundamental deficiencies in laboratory data integrity and COA authenticity.
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