Inadequate/Missing Procedures


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Warning Letter: Failure to have appropriate controls (m3955n)

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"
Failure to have appropriate controls
over computer or related systems to assure that
changes in records
are instituted only by authorized personnel, as required by 21 CFR 211.68(b). For example, see FDA-483 observation 12."

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Warning Letter: Failure to implement controls (m3488n)

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Your firm failed to implement appropriate controls over your High Performance Liquid Chromatography (HPLC) to assure that only authorized changes can be made. It was noted during the inspection that there is an option on the HPLC that allows analysts to delete results after they are processed.

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