Drugs

Central Admixture FDA-483

FDA has released the form FDA-483 issued following a 2/27-3/30 inspection at Central Admixture Pharmacy Services, an Allentown, PA, outsourcing facility. The six inspection observations were:

failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been already distributed;
written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up;
laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements;
procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed; and
failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

A similar FDA-483 was issued to Central in 6/2022. Earlier this month the company recalled injectable drugs used in hospitals due to the potential for contamination.

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