FDA warning letters target two firms in India for GMP violations, US sponsor for BIMO violations

The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing practices (cGMPs), which included issues related to data integrity.

The agency also targeted a US sponsor for conducting a clinical investigation without submitting an investigational new drug application (IND) and for failing to assume responsibility for the study. All three warning letters were posted last week.

Cdymax failed to adequately investigate OOS results

FDA issued a warning letter to the API maker Cdymax (India) Pharma Private Limited in Bangalore, India, following a four-day inspection in April 2025. During the inspection, investigators said the company failed to investigate out-of-specification (OOS) results for its APIs, which are used in parenteral products.

The company “failed to adequately investigate multiple out-of-specification (OOS) results and laboratory incidents during the testing of various samples, including raw materials, starting materials, and stability samples,” according to FDA.

The agency said that since 2023, the company has experienced approximately 1,500 laboratory incidents involving OOS results and other “significant analytical events” such as equipment failures.

In one case, the company conducted testing on a stability sample where the sample failed to meet specification limits and had an “unknown peak.” The company retested these sample preparations in their original vials. The results of all four retests were also OOS for an “unknown peak.”

The company performed a third test with fresh sample preparations and, after receiving passing results, “invalidated all earlier test results.” The company concluded that the unknown peaks “could be due to sample solution contamination during preparation.”

Yet FDA said the investigation “lacked scientific and thorough root cause analysis, failing to identify the contaminant, its origin, or the cause of its presence within your samples.” The agency stated that, since the company was unable to identify a definitive laboratory error, it should have conducted a manufacturing investigation.

Additionally, FDA said the company’s corrective action of providing refresher training for personnel on good laboratory practices “contradicted the investigation’s own initial finding that the analyst was trained and qualified to perform the HPLC [High-performance liquid chromatography] test according to your procedure.”

The company has 15 days to correct the violation noted in the warning letter.

Unexo had torn batch records on the roof

Another company based in India, Unexo Life Sciences in New Delhi, landed in hot water for numerous GMP violations related to its manufacturing of transdermal and topical patches. The agency identified these violations, particularly concerning the quality control unit, along with several instances of data integrity failings. The company was also criticized for its lax testing approach.

Inspectors discovered that the company had batch production records that were “torn in plastic bags on your rooftop.” These records were unavailable to company representatives during the inspection.

The company also lacked raw data to support the product testing for released drug products. For example, an internal test report for a patch product was missing the individual results for assay, patch weight, peel strength analysis, and rolling ball analysis. The quality management unit acknowledged that the data was missing, yet “provided no explanation when asked how you released the batch without the data.”

FDA said the company also failed to exercise appropriate controls over computer systems. For example, a QC analyst “had the ability to manipulate results, dates, and images of in-house and vendor stamp approvals on component certificate of analyses (COAs) from third-party contract laboratories, including the means to duplicate the stamp approval across multiple COAs for components…”

The company explained that the analyst who had accessed unauthorized test data was no longer employed by the company. Yet, the agency said this response was inadequate because it did not explain how “appropriate controls” would be implemented to maintain the data integrity of its computer systems.

In other areas, FDA found that air conditioner vents above production areas were “unclean.”

In October 2024, FDA held a teleconference with the company recommending a voluntary recall of drug products intended for the U.S. market. The company agreed to a voluntary recall of certain drugs “due to the significant CGMP violations.”

The recall affected a multitude of products made by the company and destined for the US market, including its Absorbine Jr. extra-large back patches, Absorbine Jr. ultra-strength pain patches, and Theracare maximum-strength pain relief lidocaine patches.

FDA told the company to notify the agency if it intends to resume manufacturing drugs for the U.S. market.

FDA rejects claims that sponsor was not responsible for clinical study

FDA issued a warning letter to Verdure Sciences in Noblesville, IN, for failing to submit an Investigational New Drug application (IND) when conducting a clinical investigation of its maple leaf extract, known as Maplifa, for photoaging.

FDA rejected Verdure’s claims that their study qualified for an IND exemption, arguing that the product is a cosmetic intended to address skin photoaging, such as wrinkles and skin brightness. The agency said that “considering the nature of the study…we conclude that the evidence collected during the inspection shows that Maplifa was intended to affect the structure or function of the body; it was not merely intended to affect cosmetic appearance.”

FDA also rejected Verdure’s claims that it was not responsible for overseeing the study because it had signed a Clinical Study Agreement (CSA) with a third-party vendor to conduct the study. According to the CSA, the sponsor's responsibilities were transferred to this third party.

The agency noted in the warning letter that “as a sponsor, you are responsible for complying with IND requirements, including submitting and having in effect an IND before initiating a clinical investigation, and it is Verdure’s responsibility, as a sponsor, to be aware of and to follow all applicable FDA regulations.”

FDA gave the company 15 business days to respond to the violations noted in the warning letter.

Cdymax; Unexo; Verdure

FDA warning letters target two firms in India for GMP violations, US sponsor for BIMO violations

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