FDA 483 - Artesanales P.R. LLC - October 23, 2023

From October 16-23, 2023, the FDA inspected Artesanales P.R. LLC, a manufacturer located at 317D St Local 3 Minillas Industrial Park, Bayamon, PR. The inspection, led by Investigator Angelica M. Hernandez, identified seven observations regarding the firm's quality system, facilities, and equipment.

**Key Observations:**

1. **No Quality Control Unit:** The firm lacks a quality control unit to ensure drug products comply with cGMP and specifications. There is inadequate oversight of investigations, deviations, annual product reviews, complaints, change control, CAPA, validation, and stability programs. The same person (Team Leader) from production performs manufacturing, approval, and release of batch records, compromising independent oversight. 2. **Inadequate Production and Process Controls:** The firm failed to establish adequate written procedures for production and process controls. Specifically, there is no validation program for processes and equipment qualification. Validation protocols/reports and qualification documents (installation, operation, performance) for the (b)(4) water system, Liquid (b)(4) Fillers, and Labeler were not provided. 3. **No Written Stability Program:** The firm lacks a written testing program for assessing drug product stability. This includes no stability procedure, protocols, or environmental control/monitoring for stability sample storage. Samples are not stored in commercial containers and are also used as retention samples. 4.