FDA 483 - Isomeric Pharmacy Solutions, LLC - June 29, 2016

The FDA Form 483 details numerous deficiencies at an outsourcing facility producing sterile injectable drug products.

**Key Violations and Observations:**

* **Inadequate Investigations:** * Investigations into unexplained discrepancies and batch failures (e.g., MedWatch adverse event EN-16001, HCG potency failures, Beta combo appearance failures, MP40 clumping complaints) lacked conclusions, follow-up, root cause identification, and corrective actions. * Non-viable particle excursions during triamcinolone production were not evaluated in the MedWatch complaint investigation. * No investigations were conducted for two HCG lots failing internal potency specifications, which were subsequently released. * Repeated Beta combo appearance failures and subsequent customer complaints (EN-160002, EN-160004) lacked adequate investigation and CAPA. * Six MP40 customer complaints (EN-160005, EN-160006, EN-160007, EN-160008, EN-16009, EN-16003) regarding clumping and sticking issues were not adequately investigated, despite both batches being sterilized using a specific method.

* **Environmental Monitoring Deficiencies:** * Negative environmental monitoring trends (e.g., MEF 1605001