Warning Letter: Failure to have procedures (ucm342647)

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Ofni Systems

We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following: 1. Failure to adequately validate a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a).

Your supplier, which was used to fill ampoules was disqualified for this service due to quality issues , but was left on your approved suppliers list because the supplier is still approved for other services. The supplier remained on the approved supplier list for all products, and/or services. There is no method for disqualifying suppliers from providing specific products and/or services. The response dated January 7, 2013 cannot be assessed at this time. Your response states that all supplier evaluation and control procedures will be revised to include an appropriate mechanism to ensure suppliers are qualified and disqualified on a product or service-specific basis. These procedures will also be reviewed to assure compliance with the Quality System Regulation . Additionally, you will also electronically prevent the issuance of purchase orders unless a supplier is approved for a specific product or service.

View the original warning letter.


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