FDA WARNING_LETTER - Ladd Family Pharmacy LLC - September 23, 2016

On September 26, 2017, the FDA issued a Warning Letter to Ladd Family Pharmacy, LLC, following an inspection from September 12-23, 2016. The inspection revealed that drug products produced by the firm failed to meet the conditions for exemption under Section 503A of the FDCA, and serious deficiencies in drug production practices were observed.

Violations included: 1. **Failure to meet Section 503A conditions**: The firm did not receive valid prescriptions for individually-identified patients for a portion of drug products. Additionally, drug products were compounded using bulk substances (acidophilus lactobacillus, coenzyme Q10, and melatonin) not eligible for 503A exemptions, as they lack USP/NF monographs, are not components of FDA-approved drugs, and are not on the 503A bulks list. This renders these products subject to FDA approval, adequate labeling, and CGMP requirements. 2. **Adulterated Drug Products (Section 501(a)(2)(A) & (B) FDCA)**: Products were prepared, packed, or held under insanitary conditions, including white powder residue in compounding hoods, use of a worn plastic store club card for filling capsules, and a disrepaired cabinet near the utensil dishwasher. Significant CGMP violations included failure to clean/maintain equipment (21 CFR 211.6