FDA 483 - Delta Pharma, Inc. - April 12, 2024

During an inspection conducted from April 9-12, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Delta Pharma, Inc., an outsourcing facility located in Ripley, MS. The observations highlight significant deficiencies in the company's manufacturing controls and quality assurance systems, particularly concerning Good Manufacturing Practices (GMP).

Key issues included a lack of established written procedures for essential in-process controls, tests, and examinations. Specifically, there were no procedures for performing supplemental visual inspections of sterile injectable drug products, such as Brompheniramine Maleate 10 mg/ml, where container closure systems limit content visibility.

Furthermore, the inspection revealed a failure to follow written procedures for the sampling and testing of components. Delta Pharma used test results from one shipment of Brompheniramine Maleate, USP API to release a distinct shipment received almost four months later, despite both sharing the same vendor lot number. This unverified raw material was subsequently used in manufacturing. Compounding this, the firm's procedures for raw material receipt did not include a statistically sound sampling plan when multiple containers were received for a single lot. These observations indicate a need for Delta Pharma to implement robust corrective actions to ensure product quality and regulatory compliance.