Algunas Inc., dba Woodland Hills Compounding Pharmacy – FDA Warning Letter, Apr 29, 2016

On July 17, 2017, the FDA issued a Warning Letter to Algunas, Inc. dba Woodland Hills Compounding Pharmacy, following an inspection from April 25-29, 2016. The inspection revealed serious deficiencies in the production of non-sterile drug products, posing patient risks.

The firm failed to meet Section 503A of the FDCA conditions for exemption from CGMP, adequate labeling, and FDA approval, specifically by not receiving valid prescriptions for individually-identified patients for a portion of its drug products. This rendered these products ineligible for exemptions.

Violations included adulterated drug products under Section 501(a)(2)(A) due to insanitary conditions, such as inadequate cleaning of work surfaces, equipment, and utensils, leading to potential cross-contamination. The ineligible drug products were also adulterated under Section 501(a)(2)(B) due to significant CGMP violations, including failure to thoroughly investigate discrepancies (21 CFR 211.192) and lack of separate areas to prevent contamination (21 CFR 211.42(c)).

Furthermore, the firm compounded unapproved new drug products, violating Sections 505(a) and 301(d) of the FDCA, and misbranded drug products under Section 502(f)(1) because they lacked adequate directions for use for lay