An FDA inspection of Isometric Pharmacy’s Salt Lake City facility revealed several GMP violations that rendered its drugs adulterated and resulted in a warning letter.
During the June inspection, FDA investigators observed GMP deficiencies related to the company’s failure to establish: a system for monitoring environmental conditions in aseptic processing areas; a testing program to assess stability characteristics; procedures to prevent microbiological contamination and ensure drugs have the appropriate identity, strength, quality, and purity; and a quality control unit with the authority to approve or reject drugs.
Other violations involved the inadequate design of the facility and the company’s poor handling of unexplained discrepancies identified in drug batches. A repeat offense from a 2015 inspection concerned the inadequate protection of the ISO 5 areas.
The warning letter also noted that Isometric produced unapproved products due to the absence of FDA-approved applications on file for its drug products.
The letter comes nearly a year after the FDA cited Isometric for similar deficiencies in a 483, following a June 2015 inspection.
In response to the new observations, the company voluntarily recalled triamcinolone diacetate injectables and suspended the production of the betamethasone acetate/betamethasone sodium phosphate injectables until adequate corrective actions have been implemented.
The FDA generally deemed Isometric’s corrective actions adequate, but asked for supporting documentation for to fully evaluate the adequacy of such actions, which included redoing smoke studies and finding alternative wipes for hard scrubbing, among other corrective and preventative measures.
The FDA is looking to shed light on the sometimes murky rules governing compounding operations primarily regulated on the state level, only adhering to USP 797 Pharmaceutical Compounding — Sterile Preparations. If you want to know how these guidances might affect your company, plan on listening to Responding to Compounding Pharmacy Inspections. Order your webinar CD/transcript today.