FDA warns drugmakers in US, Japan, and India for GMP issues

The US Food and Drug Administration (FDA) recently issued warning letters to drugmakers in Japan and the US, as well as a producer of active pharmaceutical ingredients (APIs) based in India, citing the firms for violations of current good manufacturing practice (cGMP). Additionally, the agency warned a clinical investigator for informed consent, participant screening, and other issues related to the conduct of a clinical trial.

FDA noted that the warning letter to the Indian firm Alchymars ICM was issued following an unannounced inspection.

Sato cited for inadequate microbiological controls

FDA issued a warning letter to Sato Pharmaceutical Co., located in Tokyo, Japan, on 18 May following an inspection in November 2025, which revealed significant violations of GMP at the company's sterile over-the-counter (OTC) site.

The company was criticized for three GMP failures, including failure to prevent microbial contamination in sterile drug manufacturing. FDA investigators said the company’s ISO 5 area used for aseptic filling of OTC drug products was “fundamentally unsuitable for its intended use.” In addition, the design and capability of its aseptic filling line was insufficient for maintaining a state of control.

The warning letter states that “between November 2022 and February 2025, your attempts to validate your aseptic filling line resulted in at least six media fill failures. Notably, significant microbiological and foreign particulate contamination has been found in this line. The corrective actions you implemented appear insufficient to correct fundamental factors in aseptic process design that are essential to ensure reproducibility and ongoing contamination prevention.”

The company was also reprimanded for releasing several OTC products to the US market without conducting microbiological testing, including testing products for Burkholderia cepacia. FDA said these organisms “are opportunistic pathogens of particular concern for patients with compromised immune systems or chronic lung conditions.”

Sato has since stopped exporting drugs to the US market until the problems are corrected.

FDA previously issued a warning letter on 2 February 2017 to the company for GMP deficiencies related to their monitoring of aseptic processing areas. The country’s manufacturers typically do not receive many warning letters.

Alchymars ICM cited for facility in state of disrepair

After an unannounced inspection, Alchymars ICM SM Private Limited, an API manufacturer in Tamil Nadu, India, found itself in trouble for failing to maintain its equipment and premises in proper working order.

FDA investigators found the equipment at the facility in “various levels of disrepair” with cracked, taped, and deteriorating gaskets, and rust-like residues on product-contact surfaces.

The company also failed to keep its drug manufacturing facility in a good state of repair. Specifically, the investigator found water condensation was actively falling onto the catwalk and subsequently dripping onto the working space, resulting in standing water around the working areas. Drums were placed below the water drips on the catwalk as a shield from the overhead dripping water.

FDA recommended that the company hire a consultant to evaluate its operations and assist in meeting cGMP requirements, “based upon the nature of the deviations we identified at your firm.”

The agency placed all drugs from the company on an import alert. The agency also gave the company 15 days to correct the violations noted in the warning letter.

GC America chastised for failing to test components

FDA issued a warning letter to GC America, based in Alsip, Illinois, after an inspection conducted in November 2022 revealed the company’s failure to test components to verify their identity. The company manufactures OTC dental products.

The warning letter, which did not reveal the identity of the components, states that “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 assure the acceptability of these components for use in the manufacture of your drug products.”

FDA investigators said the company also failed to have an adequate stability testing program in place. For example, the company only provided stability data for one batch, yet the batch was not tested for humidity conditions.

The company's quality unit (QU) inadequately supervised its drug manufacturing operations. For instance, a password for a meter was found stuck to a laptop with a sticker, compromising its privacy. Additionally, data from the meter is automatically deleted when the laptop is shut down, and there are no records indicating that the QU reviewed this data.

FDA said in the warning letter that “the lack of proper electronic record controls undermines the reliability and integrity of your laboratory data.”

The agency recommended that the company hire a consultant to help meet CGMP requirements. The agency also provided the company with 15 days to respond to the warning letter.

Adnan Dahdul cited for BIMO violations

Clinical investigator Adnan Dahdul received a warning letter from FDA when investigators found “objectionable conditions” during a bioresearch monitoring (BIMO) inspection involving the handling of patients enrolled in a study for an investigational drug at a site in Springfield, MA.

FDA said the investigator “violated regulations governing the proper conduct of clinical studies involving investigational products.”

Daudul failed to obtain informed consent from three subjects prior to performing the study, FDA said. In addition, Daudul also did not adequately screen subjects for any medical or psychiatric issues that would preclude their participation in the study. FDA noted that “subjects were enrolled and participated in the study despite documented evidence of medical histories and active unstable conditions such as bipolar disorder, schizoaffective disorder, schizophrenia, and illicit drug use/alcohol abuse.”

The investigator was also reprimanded for failing to maintain and provide an “adequate and accurate” case history on study subjects. For the first 196 subjects enrolled in the study, source record forms did not include study staff initials, signatures, or any information signaling who completed the entries. These records included clinical assessments, medical histories stories, laboratory sample collection and vital signs.

Other problems include source data not aligning with the information in the Electronic Data Capture (EDC) system, and missing source records. Late entry corrections were also “consistently” made to source data with no supporting documentation or explanation for the changes. 

In one case, a study subject listed a homeless shelter as a primary residence and later died during the course of the study from an alcohol and fentanyl drug overdose. The warning letter states that “the Subject’s death was documented in the EDC as a death due to cardiac arrest. However, the death certificate for the subject describes the cause of death as fatal intoxication of fentanyl and ethanol.”

The agency said that it was “not confident that your study was conducted in accordance with the investigator agreement and the investigational plan, and in accordance with good clinical practices. Additionally, we are not convinced that the study was adequately supervised. Without documented evidence, we are still not assured of the quality, integrity, and accuracy of the data collected during this study, that the rights and welfare of research participants were protected, and that your corrective action is targeted and fit for purpose.”

The investigator was given 15 days to notify FDA of any actions that have been taken to correct the violations in the warning letter.

Warning letters: Sato Pharmaceutical, Alchymars, GC America, and Adnan Dahdul