New England Compounding Center — FDA 483 Findings

There was no documentation available for the handling and disposition of reports of patient problems, complaints, adverse drug reactions, drug product or device defects, and other adverse events reported.

For the preparation of sterile drug products distributed by your firm (such as those intended for injection), there is no adequate documentation available to verify that they meet set standards (such as specifications and/or USP limits if applicable) at the time they are distributed or for the shelf life (expiration dating period) of these products.

There are no written procedures pertaining to the handling of complaints, nor does your firm maintain a complaint file.