Med Prep Consulting, Inc. – FDA 483, Apr 3, 2013

The FDA Form 483 details significant violations at a facility engaged in aseptic processing of injectable drug products in IV bags and pre-filled syringes, including Magnesium Sulfate, Heparin, Oxytocin, Dexamethasone, Vancomycin HCL, and Phenylephrine.

A primary concern is the failure to thoroughly investigate discrepancies and out-of-specification batches. Over 24 months, approximately 20 injectable drug products were incorrectly compounded, labeled, or packaged, leading to recalls for destruction or re-labeling. Examples include super-potent Zosyn and Aztreonam, mislabeled Magnesium Sulfate, incorrect Zosyn diluent, improperly packaged light-sensitive Bupivacaine, and temperature-abused Gentamicin. Investigations into these issues, and into product sterility, environmental monitoring failures, and performance challenges, were not adequately documented or did not evaluate product impact.

Microbiological testing issues include undocumented investigations into turbid broth/particle matter in products like Lidocaine and Heparin, and the use of an unvalidated, non-compendial re-test procedure. Particle count excursions were also not investigated.

Laboratory controls are deficient, lacking scientifically sound sampling plans and test procedures. The firm does not perform assay or product identification testing for any sterile injectable product. Sterility testing is performed on less than 10% of products, using unvalidated non-compendial methods. Endotoxin testing is not performed for any lot, and antimicrobial effectiveness