A barrage of inspections by FDA and state pharmacy board investigators has uncovered numerous safety violations at compounding pharmacies that supply hospitals and practitioners across the country with batch quantities of customized sterile solutions.
Most of the investigators’ on-site reports have focused on incidents of failure to maintain optimal-quality conditions and procedures for safe sterile compounding, a reflection of lax adherence to U.S. Pharmacopeia Chapter <797> standards. But some inspections also have uncovered evidence of product contamination, and several recent highly publicized cases have led to large-scale product recalls.

On May 8, for example, the FDA announced that it had concerns about a lack of sterility for drugs manufactured and distributed by The Compounding Shop of St. Petersburg, Fla., following inspections of the company's manufacturing facilities. The FDA requested that the company withdraw all of its sterile products from the market, and that any existing products not be administered to patients.
On April 17, Balanced Solutions Compounding Pharmacy, of Lake Mary, Fla., initiated a total sterile products recall “due to concerns associated with quality control processes” that led to “a lack of sterility assurance.” The recall came as a result of an earlier FDA inspection of the facility, which uncovered gram-negative bacteria in samples of the firm’s chromium chloride formulation for injection
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