H.6.Investigation: this memo is to summarize findings on the recent complaint (b)(4) against columbia cna 5% sb improved, catalog number 257306, lot number 2004161.Event description: it was reported that some plates would have show contamination.Complaint history review: the complaint trends were reviewed and similar complaints were found for this lot number.Therefore, a mrb (material review board) was performed and the results were documented within a cid (corrective and preventive action initiation determination).Batch history record (bhr) review: the batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Sample analysis: pictures were provided showing the reported contamination.The retention samples were reviewed and one plate with contamination was detected.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.Please note that this product does not have an sal claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.We only release product batches to the market with an aql (acceptable quality level) = 1.5.Although this contamination level is very low, we cannot completely exclude that a customer may receive a contaminated plate.As several complaints were reported for this product lot number regarding contamination, further evaluation will be conducted via the cid.As a root cause it could be identified that the blood pool which was used during a timely isolated production frame was contaminated.The contaminant which was also identified on one plate in the retain samples, is easy detectable as it grows before incubation.Investigation conclusion: based upon our investigation the complaint was confirmed.We would suggest to set aside, and not use, any prepared plated media that does not meet the appearance specification as it is described on the bd certificate of analysis.This is consistent with industry recommendations for inspection of culture media prior to use (e.G.¿good practices for pharmaceutical microbiology laboratories¿, who technical report series, no.961, 2011, annex 2; chapter <1117> ¿microbiology best laboratory practices¿ the united states pharmacopeia; and the difco & bbl manual).
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