FDA 483 - One Way Drug, LLC - July 19, 2017

The FDA Form 483 details significant deficiencies in a firm's drug product manufacturing, processing, packing, and holding operations.

**Key Violations and Observations:**

1. **Lack of Written Cleaning Procedures:** The firm lacks established, written, and approved procedures for cleaning equipment and utensils (blender, capsule press, glassware, spatulas) used in non-sterile drug production. Observations included a lab technician washing and rinsing glassware and vacuuming/wiping a powder press. There is no evidence to demonstrate the adequacy of cleaning procedures for removing residual products or sanitizing agents, nor are there procedures for cleaning between different batches of the same product or between different product lines.

2. **Failure to Reject Out-of-Specification Products:** Drug products failing to meet established specifications are not rejected.

3. **Release of Expired Products:** The firm has not established written procedures to ensure the identity, strength, quality, and purity of expired finished products prior to release. Several expired finished products were observed stored in the "released finished products" area, including: * Finished Product Lot # Discard Date B1/B2/B3/B5/B6, 20170407@31, 5/7/2017 * DMSO in water, 20170712@27, 7/15/2017