A company recently received this 483 observation:
….. Written procedures are not established and/or followed.
Specifically, there is no established written procedure for the transport, handling, storage, and destruction/disposal of rejected material, at the firm or disposal inventory record to track and account for the amount of rejected material destroyed by the firm. Since there is no system for tracking, identification and disposal record for rejects, there is no way to effectively ensure that rejected material is actually destroyed and not returned into the inventory for reprocessing.
For more observations pertaining to API manufacturers, see Issue 1039 available today. It also has observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.