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Your aseptic process validation does not challenge representative container closure systems currently used at your facility that represents a worst case challenge.

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For sterile API operations, smoke studies were not representative of actual operations to demonstrate unidirectional airflow and sweeping action over and away from the product under dynamic conditions during numerous aseptic operations in classified areas processing sterile APIs. He or colleague or body paragraphs with us for another letter or lab.

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Your firm failed to adequately record process details, including sample size and method of collection, to demonstrate Oxytetracycline HCI was tested in accordance with the validation protocol and approved methods.

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