FDA cites firms for CGMP violations, unapproved products, and device reporting issues

The US Food and Drug Administration has issued warning letters to several drugmakers for failing to adhere to current good manufacturing practices (CGMP) and marketing products without approval. The agency also cited an online retailer for selling unapproved opioids and a medical device company for medical device reporting lapses and making claims about their product without authorization.

CGMP

Canadian over-the-counter (OTC) drugmaker Everlaan Organics and Chinese OTC drugmaker Anhui Hanbon Daily Chemical were cited for current good manufacturing (CGMP) violations. FDA inspectors said Everlaan failed to show test evidence to ensure its final products met specifications. The company said it tests each batch of finished drug product before releasing it to the market, but the agency said it failed to provide any records to prove that it tests the final products.

"Full release testing, including for identity, strength, and impurities, must be performed prior to drug release and distribution," said FDA. "Without adequate testing, there is no scientific evidence to assure that your drug products conform to appropriate specifications before release."

Anhui Hanbon was cited for failing to test the components of its drugs for specific identity and conformity to ensure purity, strength, and quality. The agency said the company's incoming component testing only evaluated the appearance of the components and their microbiological attributes but did not include identity testing or testing for contamination.

Similarly, Everlaan was cited for failing to test the identity of each component used to make its drug products. The company argued that it identifies the components based on receiving practices, but the inspectors said its procedures do not include conducting chemical testing for incoming components. They noted that without such testing and testing data, there is no scientific evidence that the components conform to specifications before they are used to manufacture the final products, and it is the manufacturer's responsibility to test incoming components.

FDA said Anhui Hanbon failed to have release testing procedures to ensure the final product met quality attributes or establish a written testing program to ensure the stability characteristics of their final products.

"Your firm failed to establish an adequate stability program, which includes data from long-term or accelerated storage conditions to demonstrate that your product remains acceptable throughout its labeled expiry period," said the agency. "Without appropriate stability studies, there is no scientific evidence to support that your drug product retains its quality attributes throughout the labeled [redacted] expiry period."

Everlaan was also cited for failing to have a written testing program for stability testing their products, proper production record-keeping, and a quality unit that exercised its authority to ensure products met quality standards.

"The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations," said FDA. "Specifically, your QU did not adequately exercise its authority in the approval or rejection of components, approval or rejection of finished drug products, batch record review, establishment and implementation of an adequate stability study program, and performance of adequate process validation."

FDA recommended Anhui Hanbon get a qualified consultant to help it evaluate its operations and meet CGMP requirements.

"The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your [corrective actions and preventive actions (CAPA)] before you pursue resolution of your firm’s compliance status with FDA," said the agency. "Your use of a consultant does not relieve your firm’s obligation to comply with CGMP.

"Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance," it added.

Everlaan notified FDA that it plans to halt production and instead outsource it to a contract manufacturing organization (CMO). However, the agency noted that the contract manufacturing facility it has proposed using was placed on an import alert for failing to comply with CGMP requirements.

"Drugs manufactured at your prospective CMO are considered adulterated and thus should not be used for the manufacture of drugs for the United States market," said FDA. "You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities."

Unapproved products

In addition to the CGMP violations, Everlaan was cited for marketing its Maple Organics Joint Therapy, Muscle Pain Relief, Cough & Cold Relief, and Cough & Cold Relief for Kids without FDA approval. The agency noted that the drugs are not considered generally recognized as safe and effective (GRASE) and do not meet requirements for marketing as an OTC monograph drug. More specifically, it noted that the drugs include certain active ingredients, such as arnica, that require regulatory oversight.

"Although your firm does not specifically list arnica as an active ingredient, your labeling of 'maple organics Joint Pain Relief,' such as your website, includes statements that claim arnica is intended as an anti-inflammatory and analgesic, and '…provides fast-acting, long-lasting relief from discomfort caused by osteoarthritis, tendonitis, and rheumatoid arthritis,'" said FDA. "Such statements demonstrate that arnica is an 'active ingredient' in your 'maple organics Joint Pain Relief' because it is intended to furnish pharmacological activity or other direct effect to affect the structure or any function of the body of humans.”

Similarly, the agency said its cold relief drugs violate regulations because they claim to follow FDA standards when that is not the case and the directions for use are inadequate.

FDA also cited the website www.usaquickmeds.com for selling opioids and benzodiazepines without approval. The agency highlighted that opioid addiction is a public health crisis that has led to a staggering death toll, and the easy availability of opioid products on the Internet poses a significant public risk.

"Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs," said FDA. "Further, in cases where benzodiazepines were co‐used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone.

"Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines," the agency added. "The easy availability of benzodiazepines via the Internet poses additional significant risks to US consumers."

"FDA is sending this warning letter to www.usaquickmeds.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs," said FDA. "You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above).

Les Encres

Tennessee-based Les Encres, a manufacturer of absorbable polydioxanone (PDO) surgical suture devices, also received a warning letter from FDA for quality system violations. The company was cited for failing to receive, review, and evaluate product complaints through a designated unit, having adequate procedures to implement CAPAs, and maintaining procedures to ensure its products conform to specified requirements.

"Specifically, you do not have a procedure that describes the process by which suppliers, contractors, or consultants are evaluated and how their approval status is documented," said FDA. "You did not document the results of any evaluation performed by you that qualifies your supplier of absorbable PDO surgical sutures."

Les Encres was cited for failing to follow medical device reporting (MDR) requirements, and FDA recommended that it create an active Electronic Submissions Gateway (ESG) production account to submit electronic MDR reports. While Les Encres Threads are indicated for soft tissue approximation, the agency also cited the company for selling the products without marketing authorization for specific uses. It notes that on the company's website it states the products can be used for lifting, tightening and adding volume; and is ideal light cheek lifts, jawline lifts, neck lifts, brow lifts and lower face treatments.

"We discussed these issues with you in 2024 regarding promotion of your devices with statements beyond the scope of the cleared 510(k)," said FDA. "FDA is currently unaware of any evidence you have submitted that could support the above intended uses of your devices.

"Your firm should take prompt action to address any violations identified in this letter," the agency added. "Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice."

Warning letters

FDA cites firms for CGMP violations, unapproved products, and device reporting issues

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