FDA warns three firms for GMP violations, cites Incyte for misleading claims
The US Food and Drug Administration (FDA) recently issued three warning letters to facilities in China, the US, and India for noncompliance with current good manufacturing practices (cGMPs). Additionally, FDA sent an untitled letter was to Incyte for making misleading claims about a product on its website.
Intas Pharmaceuticals
FDA sent a warning letter to Intas Pharmaceuticals in Ahmedabad, India for multiple GMP violations, including inadequate investigations into out-of-specification (OOS) assay results. The company makes generic formulations, biosimilars, and active pharmaceutical ingredients (APIs).
The company received a warning for failing to conduct thorough OOS investigations. The warning letter states that “after the initial OOS result, you proceeded to test samples from the same batch and other previously OOS batches, using a revised analytical method with a different sample preparation and obtained different results. Despite using the revised analytical method, two batches (b)(4) and (b)(4), (b)(4) tablets USP (b)(4) mcg and (b)(4) mcg) remained out of specification. Your investigation failed to evaluate why these batches still failed or assess whether the analytical method itself contributes to result variability.”
The agency also said Intas lacked adequate quality controls to ensure the integrity of its electronic batch records. The letter states that “your quality assurance employee instructed your software vendor to make changes to your electronic batch record which were not captured in the audit trail or managed through your quality system.”
Intas received a warning letter for similar violations in November 2023. (RELATED: FDA warning letters address CGMP, clinical study plan failures, Regulatory Focus 4 December 2023)
Foshan Miwei
FDA issued a warning letter to Foshan Miwei Cosmetics in Guangdong Province in China for violations tied to its manufacturing of OTC products, including Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer.
Among the violations was a failure to test products for the strength of each active ingredient prior to release and distribution. The company also failed to conduct adequate microbiological testing for each batch of its OTC drug products. For example, its certificates of analysis (COAs) lacked active ingredient assay values and results for certain microorganisms.
FDA also scolded the drugmaker for failing to conduct identity testing of components used in the manufacturing of its drug products.
The warning letter reminded the company that “identity testing for (b)(4) and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of (b)(4). Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of this component for use in the manufacture of your drug products.”
Foshan Miwei also failed to establish an adequate stability program demonstrating that the drug products remain acceptable throughout its labeled expiration date.
FDA also took the company to task for failure to provide adequate quality unit (QU) oversight of its products. For example, the company failed to review, approve, or implement procedures for critical quality operations, including handling non-conformances, controlling changes, overseeing training, and addressing OOS failures.
The agency placed these products on an import alert on 13 February 2026.
Lexia did not conduct release testing or component testing
FDA issued a warning letter to Lexia LLC in Franklin, TN, for several of violations tied to its manufacturing of OTC topical pain relief products.
One was the company’s failure to adequately conduct finished product release testing for each batch of product. The company only tested the final drug product for viscosity, pH, and color.
The company also failed to test incoming components and did not establish a vendor qualification program for your raw material suppliers. “Your firm used results from your suppliers’ certificates of analysis (COAs) without establishing the reliability of your suppliers’ analyses through appropriate validation and without conducting at least one specific identity test on each incoming lot of components. You cannot rely on your suppliers’ COAs to verify the identity of your components.”
FDA also objected to Lexia’s failure to conduct stability testing of its products. As a consequence, FDA said “there was no assurance that your drug product will remain acceptable throughout its labeled expiry period without an established stability program. During the inspection, you stated that your product’s expiry is ‘anecdotal.’”
The company also lacked process validation data to demonstrate that the manufacturing process was reproducible to “consistently yield drugs of uniform character and quality.”
Finally, the FDA stated that the company did not have a quality unit (QU) with appropriate oversight for the manufacturing of its drug products.
The company has since stopped producing OTC drugs at the facility.
FDA cites Incyte for misleading claims
FDA’s Office of Prescription Drug Promotion (OPDP) took Incyte to task in a recent untitled letter for making misleading claims on its website for its chronic graft-versus-host disease (cGVHD) treatment Niktimvo (axatilimab-csfr).
The Wilmington, DE-based firm overstated the product’s efficacy on its website, said FDA. The company claimed that “most people achieved a response with Niktimvo” and “75% of people (59 out of 79) experienced a response.”
The agency stated that “these claims misleadingly overstate the efficacy of Niktimvo by suggesting that Niktimvo has demonstrated complete responses in patients with chronic graft-versus-host disease (cGVHD), when this is not the case. According to the CLINICAL STUDIES section of the FDA-approved Prescribing Information (PI), no patients experienced a complete response (CR), and all 59 responding patients experienced only a partial response (PR) to Niktimvo.”
The company faced criticism for asserting that its product “may provide fast and lasting responses across a range of affected organs” while displaying a diagram of the human body that highlights specific “affected organs” and their response rates.
FDA states that this presentation “misrepresents the efficacy of Niktimvo because it creates a misleading impression of the treatment benefit of Niktimvo across organ systems. According to the CLINICAL STUDIES section of the PI, the efficacy of Niktimvo was based on overall response rate (ORR) through Cycle 7, Day 1, where overall response included CR or PR based on assessment of cumulative response across all organs, not specific individual organs.”
