FDA 483 - Wedgewood Connect, LLC - October 07, 2014

The FDA Form 483 details observations from an inspection, citing multiple deficiencies in the facility's operations related to sterile drug product manufacturing and quality control.

**Violations and Observations:**

1. **Microbiological Contamination Prevention:** Procedures for preventing microbiological contamination of sterile drug products were not followed. Specifically, SOP 4.040, effective 07/14/14, for the "Use, Validation and Maintenance of the redacted" was deficient. The firm failed to perform validation studies for redacted sterilization and/or depyrogenation cycles using the redacted. Section 9.7.1 of the SOP lacked specific procedures and parameters for performance qualification of redacted sterilization, and Section 9.7.2 (b) (4) for glassware depyrogenation validation was deficient as it did not specify the redacted for glassware depyrogenation.

2. **Sterilization Monitoring:** The firm has not used the redacted for production runs to monitor sterilization effectiveness since operations began on 07/21/2014. Real-time assessment of sterilization redacted, such as redacted, to verify set redacted were met, was not performed. Examples of sterile injectable and ophthalmic suspensions redacted sterilized since 07/21/2014 include 500 ml Glycerin 99.5% Preserved Ophthalmic Suspension (lot 08132014@72),