FDA 483 - Colonia Care Pharmacy - April 15, 2016

The FDA Form 483 details significant deficiencies in the manufacturing and quality control of sterile drug products. A primary concern is the lack of a written testing program for assessing drug product stability, leading to insufficient data supporting Beyond Use Dates (BUDs) for injectable products and in-process sterile-filtered stock solutions. For example, Papaverine/Phentolamine/Prostaglandin-E1 Injection Solution (Trimix), lot 020216A, had an expired Papaverine stock solution used in its preparation, and neither the finished product nor its stock solutions were tested for sterility, potency, purity, or endotoxin levels at the end of their BUDs. Stock solutions were stored in unclassified areas, and preservative effectiveness in multi-use vials was not assessed. Similar issues were noted for Methylcobalamin and Acetylcysteine Injection Solution, lot 120715M, including unverified container-closure suitability. Dexamethasone 24mg/ml Injectable, lot 031716N, had an incorrect BUD label and lacked supporting test data.

Furthermore, the facility fails to perform appropriate laboratory determination of satisfactory conformance to final specifications, identity, and strength of active ingredients prior to release. Specifically, not all finished sterile drug products are tested for sterility and endotoxin levels, and there is no testing schedule. Examples include the aforementioned Trimix and Methylcobalamin/Acetylcysteine injections