FDA 483 - Pharmagen Laboratories, Inc - August 23, 2013

The FDA conducted an inspection of Pharmagen Laboratories, Inc., a sterile injectable drug manufacturer located at 30 Buxton Farms Road, Suite 110, Stamford, CT 06905, from August 5 to August 23, 2013. The inspection revealed significant deficiencies across quality systems, facilities, equipment, and testing procedures.

Key observations include: - **Lack of a Quality Control Unit (QCU):** No QCU separate from production exists, with the Pharmacy Manager operating in production and approving product release. There are no written procedures for QCU roles, and procedures lack qualified personnel approval. Several lots (Acetylcysteine, Nalbuphine, Sodium Phosphates, Dextrose PF) were distributed without or prior to release signatures. - **Process Validation Deficiencies:** No process validation for deviations in Dextrose production, including pooling of lots and capping in unclassified areas without hold time data. Deficiencies were noted in testing for repeater pump use, and no microbial retention studies or qualification for product interaction with the pump itself. Media fills lacked growth promotion for prepared media. - **Inadequate Batch Records:** Master batch records are not approved by a QCU. Logged Formula Worksheets lack actual ingredient weights, second verification of components, product yield calculation, and labeling reconciliation. - **Contamination Control Deficiencies:** No smoke studies in classified areas (clean room, horizontal flow hood, isolator), and ISO