FDA 483 - Clarcon Biological Chemistry Laboratory Inc. - May 04, 2009

The FDA Form 483 inspection revealed numerous deficiencies at the facility. A primary concern is the absence of a quality control unit (QCU), with Dr. Bonada claiming sole responsibility for both QCU functions and manufacturing, and no written QCU responsibilities.

Significant manufacturing process control issues were identified, including the lack of validation for drug manufacturing processes, equipment cleaning, purified water manufacturing, and laboratory methods. Master production and control records are not prepared, dated, or signed, and no written procedures exist for their preparation. Batch production and control records are incomplete, missing critical information such as component identification, in-process and laboratory control results, packaging area inspections, yield statements, labeling control records, container descriptions, sampling details, personnel identification, investigation records, and examination results.

Finished product testing is deficient, as the firm does not test for the identity and strength of the active ingredient, benzalkonium chloride, prior to release. Employee training in current good manufacturing practices (cGMP) is undocumented. The facility lacks written procedures for production and process controls, and for the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components, drug product containers, and closures.

Equipment and containers are improperly identified, with various unidentified containers of finished product found in production and storage areas. There is no written stability testing program, and no stability data to support expiration dating. Active ingredient samples are not retained. Equipment maintenance, cleaning, sanitizing, and inspection