FDA 483 - Ranier's Compounding Laboratory - February 13, 2024

During an inspection conducted from February 5 to February 13, 2024, the Food and Drug Administration (FDA) issued a Form 483 to Rainier's Compounding Laboratory. The inspection revealed two significant observations related to the production of non-sterile drug products. Firstly, evidence of vermin was found in the general compounding lab area; specifically, dead insects were observed within ceiling lights where various drug suspensions were prepared. This particular issue was noted as a repeat observation from a previous FDA 483 in 2021, indicating a persistent problem with environmental control. Secondly, the firm was cited for using ingredients not intended for pharmaceutical applications in both human and veterinary drug products. A non-compendial, store brand ingredient was utilized in the preparation of Lidocaine/Prilocaine/Tetracaine/Phenylephrine Dental Paste, which was subsequently distributed to patients. This highlights a failure to adhere to appropriate quality standards for raw materials. These observations indicate potential violations under Section 704(b) of the Federal Food, Drug and Cosmetic Act, which addresses conditions where drugs may be prepared or held under insanitary conditions or become contaminated. Rainier's Compounding Laboratory is required to respond to these observations by outlining corrective actions to ensure compliance and patient safety.