FDA 483 - ImprimisRx Pharmacy LLC - August 01, 2016

The FDA Form 483 details significant deficiencies at a drug compounding facility. The quality control unit lacks adequate laboratory facilities for testing components, drug product containers, and drug products. Specifically, no testing is performed for potency or microbiological levels in aqueous solutions, suspensions, encapsulated powders for inhalation, and oral capsules. For example, Budesonide 0.6mg/2ml Solution Lot 06292016:44 lacks potency testing, and the master batch record does not define the production process.

The firm has not conducted sufficient stability testing to support assigned Beyond Use Dates (BUDs) of 30, 60, 90, or 180 days for various products, including those packaged in clear, colorless plastic unit-dose ampules labeled to protect from light. Data supporting current BUDs often originated from other pharmacies or a decommissioned production room, lacking supporting documentation. Additionally, APIs and excipients are used past their expiration dates, such as Betamethasone API with an August 31, 2016 expiration used for a product with a September 20, 2016 BUD.

Written procedures for production and process controls are inadequate. The clean room HEPA filters and ISO-5 hoods are not certified, with a damaged HEPA filter awaiting replacement. Gowning procedures are insufficient, with personnel observed moving in and out of the production area without proper re-gowning, and clothing dragging on