FDA Policy/General

FDA Cites Formulated Solutions Over Manufacturing, Quality

FDA has issued an untitled letter to contract manufacturer Formulated Solutions, citing GMP violations related to component testing and quality oversight at the company's Largo, FL, facility.

In the 6/2 letter, FDA said its review of records submitted by the company in response to a September 2025 records request found that the firm's manufacturing controls did not conform to GMP requirements for finished pharmaceutical products, rendering its over-the-counter drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

The agency identified two primary deficiencies.

First, FDA said Formulated Solutions failed to adequately test incoming drug components for identity, purity, strength and quality before use in manufacturing. According to the agency, the company relied on supplier certificates of analysis (COA) without demonstrating that it had appropriately validated the reliability of supplier test results. FDA also said the firm's identity testing did not fully conform to current United States Pharmacopeia standards.

Second, FDA found that the company's quality control unit failed to adequately ensure that drug products were manufactured in compliance with GMP requirements. The agency said Formulated Solutions lacked procedures to verify supplier COA data at appropriate intervals and that its quality unit approved materials for manufacturing without ensuring compliance with regulatory standards.

FDA directed the company to submit a comprehensive remediation plan, including revised procedures for component testing, supplier qualification and COA validation, as well as an assessment of whether its quality unit has sufficient authority and resources to oversee manufacturing operations.

The agency noted that Formulated Solutions previously indicated it no longer manufactures or distributes drug products containing certain ingredients identified in the review and said the company must notify FDA if it intends to resume production of such products.

FDA also reminded the company that, as a contract manufacturer, it remains responsible for the quality of products it produces regardless of agreements with product owners. Contract facilities are considered extensions of the drug manufacturer and must ensure products meet standards for safety, identity, strength, quality and purity, the agency said.

Formulated Solutions has 30 working days to respond with corrective actions and plans to prevent recurrence of the cited violations, according to the letter.

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