The US Food and Drug Administration (FDA) has issued warning letters to a device maker and several drug makers for failing to meet quality system and current good manufacturing practice (CGMP) requirements. The agency has also cited more than two dozen telehealth companies for marketing compounded glucagon-like peptide-1 (GLP-1) receptor agonist drugs without authorization.
Zoll Medical
FDA cited Zoll Medical for several quality system regulations and medical device reporting violations. The Maine-based company, which makes defibrillators, ventilators, and other medical devices, failed to establish and maintain procedures for corrective and preventive action (CAPA), according to the agency. Investigators listed several instances in which they said the company failed to implement CAPAs when it received complaints or encountered nonconforming products and other quality problems.
Zoll was also cited for failing to establish and maintain procedures for validating device design, including failure to verify and validate a labeling change of their 731 MRI-compatible ventilators. Furthermore, the company was cited for failing to establish and maintain procedures to ensure that the products and services it purchases meet the required specifications.
Additionally, FDA cited Zoll for failing to follow MDR reporting requirements, including incidents where there may have been a reasonable concern of a product malfunction, and the company didn't notify the agency within the required timeframe.
"For example, the information included for Incident No. 1095284 reasonably suggests that your firm’s ventilator malfunctioned (i.e. insufficient user instructions that led to an unexpected shutdown) while operating near an MRI," said FDA. "The information included in the complaint reasonably suggests that the malfunction would be likely to cause or contribute to a death or serious injury, if it were to recur.
"Therefore, the referenced complaint represents an MDR reportable event as defined in 21 CFR 803.3(o)," the agency. "Your firm became aware of the event on June 20, 2024, and FDA received the MDR, 1220908‐2025‐00947, for the corresponding incident on March 10, 2025, which is beyond the 30‐calendar day timeframe."
Sante, Pharmathen, and InvaDerm
FDA issued warning letters to three drug manufacturers, including the Canadian over-the-counter drugmaker Sante Manufacturing, for failing to adhere to CGMP requirements.
The agency said Sante failed to conduct tests to verify the identity of each component of their drug products, and to validate and establish the reliability of the components it receives from its suppliers at appropriate intervals.
FDA noted that one of the incoming components used in its manufacturing is known to be high-risk for contamination and Sante relied on the supplier's certificate of analysis rather than conducting its own testing to ensure the component met requirements.
"The use of ingredients contaminated with [redacted] has resulted in various lethal poisoning incidents in humans worldwide," said FDA. "See [redacted] to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for [redacted] contamination at [redacted].
"Without adequate testing and confirmation of reliability of supplier test results, you lack scientific evidence that the components or drug products conform to appropriate specifications prior to use in the drug products you manufacture," the agency added.
Sante was also cited for failing to have proper written procedures and process controls to ensure its final products meet identity, strength, quality, and purity requirements. The agency also said it the company's quality control unit (QU) failed its responsibility to ensure its products were manufactured in compliance with CGMP, and the final products met specifications.
"Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP," said FDA. "In addition to the lack of effective management oversight of your production operations, we found your QU is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities.
"Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements," the agency added.
Ultimately, FDA said that Sante should engage with a qualified consultant to help it address its CGMP shortcomings. More specifically, the agency recommended that the consultant conduct a six-system audit of its operations to assess CGMP compliance and evaluate its CAPA processes.
Similarly, FDA sent a warning letter to Greek drugmaker Pharmathen International for CGMP violations. The company was cited for failing to implement proper procedures to prevent microbiological contamination of sterile products. The agency noted that the airflow studies of its manufacturing procedures, intended to ensure they were produced in aseptic conditions, failed to show unidirectional airflow, and instead, it was observed that the airflow reentered the filling line.
"Our inspection also found multiple instances of gram-negative microbes in ISO 5 air samples. It is highly atypical to find gram-negative microbes in an aseptic processing room environment," said FDA. "In one such instance, you attributed the probable cause of gram-negative microbial contamination to room disinfection practices and [redacted] contamination.
"It is essential that you thoroughly investigate the recurring identification of gram-negative microbes in your aseptic processing environment to determine the root causes and fully remediate with appropriate actions," the agency added.
Pharmathen was also cited for failing to investigate unexplained discrepancies and batch failures to ensure the final product met specifications.
"Your firm did not adequately investigate out-of-specification (OOS) and out-of-limit (OOL) results," said FDA. "Your investigations of sterility failures and significant environmental monitoring excursions lacked adequate scientific rationale to support root causes and implementation of effective CAPA.
"Your firm did not implement effective CAPA to reduce recurrence of severe contamination hazards including, but not limited to, operator error that had contributed significantly to recurring sterility and media-fill failures over the past five years," the agency added.
Additionally, the FDA said Pharmathen failed to ensure manufacturing operations were conducted within appropriately defined areas to prevent product contamination and to properly document laboratory control mechanisms. More specifically, the agency said its microbiological laboratory records were inadequate, and its investigators found that microbial plates in its incubators lacked appropriate documentation.
"We also noticed that critical CGMP documentation forms used to document test results printed from your IQVIA software (e.g., sterility test report) are not adequately controlled," said FDA. "Proper document control and data management is foundational to CGMP to ensure the availability and integrity of data.
"Data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA) to ensure complete and accurate records," the agency added.
Finally, FDA said Pharmathen's quality system lacks data integrity, and asked the company for more information on its remediation efforts. While the company said it would cease manufacturing and distributing all drugs for the US market until it completes its CAPAs, the agency asked it to update it on when it plans to resume production for US products.
"If you plan to resume any sterile manufacturing operations regulated under the FD&C Act, notify this office before resuming those manufacturing operations," said FDA. "You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance.
"In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA," the agency added.
FDA also sent a warning letter to New Jersey-based InvaDerm for marketing drugs that have not been approved by the agency. The agency said it has not been reviewed for safety and efficacy and therefore does not meet its requirements to be considered generally recognized as safe and effective.
Telehealth GLP-1 marketers
In addition to sending warning letters to drug and device manufacturers, FDA sent warning letters to 25 telehealth companies for marketing compounded GLP-1 receptor agonist drugs, including semaglutide and tirzepatide products. This isn't the first time that the agency has targeted telehealth companies and compounding pharmacies for marketing the popular weight-loss drugs without authorization.
FDA issued warning letters that used boilerplate language, citing the companies for illegally marketing the drugs.
"Compounded drug products are not FDA-approved," said FDA. "Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
"You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur," the agency added. "It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations."
https://www.raps.org/resource/fda-cites-companies-for-cgmp-violations-telehealth-firms-for-illegally-marketing-glp-1-drugs.html
