FDA warns firms for CGMP violations, unauthorized sales of weight-loss drugs

The US Food and Drug Administration (FDA) has warned several drug manufacturers for failing to comply with current good manufacturing practice (CGMP) and, in two cases, for operating facilities under insanitary conditions. The agency also warned two companies for illegally marketing drugs used for weight loss.

On 13 February, FDA published five warning letters that it recently sent to firms for failing to comply with its regulatory requirements. Three of the letters were sent to drugmakers for failing to adhere to CGMPs.

FDA sent a warning letter to Madhu Instruments Private Limited, a drugmaker based in New Delhi, India on 1 February. The agency said inspectors found insanitary conditions at its manufacturing facility that could contaminate its sterile products.

“FDA investigators observed that products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your products to be adulterated,” said FDA.

Inspectors said they found paint peeling from the ceilings, a plastic bag blocking the high-efficiency particulate air (HEPA) filter that cleans the air, broken tiles with residue on them, and unconventional methods used to patch holes and hold to secure objects to the walls in the manufacturing facility.

FDA also sent a warning letter to Texas-based outsourcing facility QuVa Pharma on 26 January. Investigators visited the company’s manufacturing facility in Bloomsbury, NJ, and similarly noted that drugs were prepared and packed under insanitary conditions.

Specifically, FDA said the company failed to take proper corrective actions after mold was found on operator glove finger plate samples, and operators were observed placing their body in the way of airflow under a hood in the facility. It was also cited for, among other faults, for not following appropriate written procedures to prevent microbial contaminations.

“We have reviewed your facility’s responses to the Form FDA 483,” said FDA. “Some of your corrective actions appear adequate; however, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation.”

FDA also sent a warning letter to Ningbo Poplar Daily-Use in Ningbo, China, on 5 February for CGMP violations. The agency said the company failed to institute proper testing of the raw materials going into manufacturing their drugs or testing to ensure the final product conformed to specifications. The company was also cited for failing to establish proper stability testing requirements to determine their drugs' appropriate storage conditions and expiry dates.

“Based on the records and information you provided for stability, you did not demonstrate that the chemical properties of your drug products remain acceptable throughout the labeled expiry period of 24 months,” said FDA. “Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.”

Unapproved drugs
In separate warning letters, FDA admonished two companies that sell unapproved versions of the type 2 diabetes and weight-loss drugs semaglutide and tirzepatide on their websites.

FDA sent a letter to US Chem Labs based in Miami, FL, on 7 February warning the company for selling the drugs on its website.

“Despite statements on your product labeling marketing your products as ‘research chemicals only’ and ‘not for human consumption,’ evidence obtained from your website establishes that your products are intended to be drugs for human use,” said the agency.

In particular, FDA said it is concerned that the company is marketing thymalin for use in children.

“Your product has not been evaluated by FDA for safety, effectiveness, and quality,” said the agency. “The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations such as children and infants who may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.”

On the same day, FDA sent Synthetix Inc. DBA Helix Chemical Supply based in Bronx, NY, a warning letter for also marketing semaglutide and tirzepatide on its website without approval. While the company uses language describing the drugs as being for “research use only” and “not for human consumption,” FDA said the company’s marketing of the products contradicts those statements.

FDA warns firms for CGMP violations, unauthorized sales of weight-loss drugs

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