Portage Pharmacy Inc. – FDA 483, Mar 6, 2013

The FDA Form 483 documents significant deficiencies in a drug manufacturing facility, particularly concerning sterile drug production and quality control.

**Facility and Operation Details:** The facility manufactures various injectable drug products, including Hydroxyprogesterone Caproate, Chorionic Gonadotropin (HCG), Human Chorionic Gonadotropin Injection, and TriMix (Papaverine/Phentolamine/Prostaglandin E1 Injection). The operations involve sterile processing and handling of penicillin, which is not segregated from other drug products.

**Violations and Observations:** * **Microbiological Contamination Prevention:** Procedures (SOP 8.020) for using Biological Indicators (BIs) in sterilization loads are not consistently followed or recorded. For example, Hydroxyprogesterone Caproate 250mg/ml Injectable lot 0213131 lacked BI records. * **ISO 5 Smoke Studies:** Smoke studies for ISO 5 hoods are deficient, lacking video recordings, only noted in one certification report, and performed only in static conditions. * **Batch Production Records:** In-process results are not included in batch production and control records. * **Environmental Monitoring:** Aseptic processing areas have deficient environmental monitoring systems. ISO 5 hoods are not monitored each time a sterile drug is formulated (e.g., Chorionic Gonadotropin (HCG) 2000IU/ml Injectable