Initial reporter phone: (b)(6).H6.: investigation summary: complaint history review: complaint history was reviewed, and similar complaints were identified for this catalog number.However, no trend was identified.Batch history record (bhr) review: the batch history record was reviewed, and no discrepancy was detected.Sample analysis: the retain samples were reviewed and the issue could not be observed.Neither picture nor return samples were provided.Evaluation results: after investigations, no deviation could be detected in our validated manufacturing process.No deviation could be detected neither during the review of the retain samples nor during review of the batch history record.Since neither picture nor return were provided no further investigation could be performed.Investigation conclusion: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.This product does not have an sal (sterility assurance level) claim.It is filled aseptically; therefore, an occurrence of a contamination event cannot be entirely ruled out.Please note that the valid standard for these products is din en 12322 "in vitro diagnostic medical devices - culture media for microbiology".According to this standard the contamination rate for each product lot must not exceed 4.9%.Based upon our continuous monitoring, we derive a contamination rate that falls below this specified value.According to our high-quality standard, we only release product batches to the market with an aql (acceptable quality level) = 0,65.Although this contamination level is very low, we cannot completely exclude that a customer may receive contaminated plates.Based on the above-mentioned evaluation, the complaint cannot be confirmed.
|