Warning Letter: No Procedures for Controlling Worksheets (ucm218221)

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Ofni Systems

Your firm has no procedures for controlling laboratory worksheets including changes to worksheets, issuance of laboratory worksheets, and reconciliation of laboratory worksheets. The worksheet “Internal Communication – Batch Release Information” by the warehouse, which is used to identify released product, was created after [redacted] documented release of finished product for Heparin I.V. Flush Syringes and Normal Saline I.V. Flush Syringes prior to obtaining media fill results. This sheet is used to communicate batch release information to warehouse operations. Use of this sheet is not documented in any Medefil procedure nor is control over this sheet documented.

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