FDA 483 - Algunas Inc., dba Woodland Hills Compounding Pharmacy - October 11, 2018

During an inspection conducted by the Food and Drug Administration (FDA) from October 4 to October 11, 2018, Algunas Inc., operating as Woodland Hills Compounding Pharmacy, received an FDA Form 483. The inspection identified a significant observation related to the quality of components used in drug formulations. Specifically, the pharmacy was observed using a non-pharmaceutical grade component in various non-sterile drug products since 2017. Instead of utilizing USP (United States Pharmacopeia) grade ingredients, the firm employed a different system without routinely testing its production quality or assessing contamination risks. This practice directly affects the quality and safety of numerous compounded products, including topical facial pads, solutions, dental gels and rinses, and enemas. The issuance of an FDA Form 483 signifies inspectional observations of conditions that may constitute violations of the Food, Drug, and Cosmetic Act. While this document does not represent a final regulatory determination, it requires the company to address the identified deficiencies. Woodland Hills Compounding Pharmacy is expected to implement corrective actions to ensure all components used in drug manufacturing meet appropriate pharmaceutical standards, thereby safeguarding product quality and patient safety.