FDA sends warning letters to Amazon, three OTC drugmakers, and a drug compounder
The US Food and Drug Administration (FDA) has sent another warning letter to online retail giant Amazon for distributing unapproved new drugs. Additionally, three manufacturers of over-the-counter (OTC) medications received warnings for good manufacturing practice (GMP) violations, and a drug compounding pharmacy was warned for making sterile drugs under unsanitary conditions.
All five warning letters were posted on April 29, and all were sent to manufacturers or distributors in the United States.
Amazon cited for distributing unapproved new drugs
FDA’s warning letter to Amazon cited the company for distributing unapproved new drugs intended for use as external analgesics on the skin during or after tattooing, piercing, or laser hair removal.
The letter states that “your firm is responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs under section 505(a) of the [Federal Food, Drug, and Cosmetic Act] FD&C Act, 21 U.S.C. 355(a).” It further noted that “introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. 331(a) and (d).”
FDA said it purchased seven offending products via Amazon’s website, including “Painless Tattoo: Tattoo Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%.”
“FDA has safety concerns about external analgesic drug products formulated with active ingredients at concentrations that exceed levels currently permitted for nonprescription external analgesic products, because they are intended to be used before or during certain cosmetic procedures in ways that could lead to increased absorption of the drug product through the skin,” the agency wrote.
The products also do not conform to the OTC Monograph M017 governing external analgesics for OTC use, FDA said.
FDA has been cracking down on online retailers for selling unapproved drug products. Amazon was also cited in two other recent warning letters for similar violations.
Other recent actions against the company include a warning letter sent in March 2025 for distributing injectable products used to dissolve fat and a warning letter in 2023 for selling unapproved drugs to treat a viral skin condition. (RELATED: FDA warns Amazon, Walmart and others for selling unapproved drugs for viral skin infection, Regulatory Focus 22 August 2023)
Cosco International failed to validate manufacturing processes
FDA also cited Cosco International for numerous GMP violations for its (OTC) products Berberex Wound Gel, Asystem Pain Roll On, Forticept Antimicrobial Gel, and Forticept Antiseptic Ear Flush.
FDA inspected the Marietta, GA-based firm in October 2024 and cited it for failing to validate its manufacturing processes for OTC drugs, including topical drugs intended for wound treatment in children.
“You failed to adequately validate your manufacturing processes to demonstrate that your processes are reproducible and controlled to consistently yield drug products of uniform character and quality. For example, your OTC drug products, Berberex Wound Gel, Asystem Pain Roll On, Forticept Antimicrobial Gel, and Forticept Antiseptic Ear Flush, were manufactured without adequate process qualification studies,” said FDA.
The company failed to conduct cleaning validation studies for making products produced on shared equipment. These products contain active ingredients such as menthol, benzalkonium chloride, lidocaine, or ketoconazole, in addition to manufacturing cosmetic items. FDA said that the company “failed to demonstrate that your cleaning procedures can prevent potential cross-contamination between the various drug and cosmetic products mixed and filled on the same shared equipment.”
The firm also lacked stability data to show that the product met specified standards. The company distributed drugs intended for wound treatment without conducting accelerated or long-term stability studies.
Additionally, the company failed to test its products for bacteria, fungi, and objectionable microorganisms, such as Burkholderia cepacia complex (BCC), and Pseudomonas species in its water testing.
Dyno International did not test components
Dyno Manufacturing was also cited for violations concerning component testing and failing to have a stability testing program for its OTC hand sanitizers and antibacterial hand soap products.
The company, based in Madison, IL, failed to adequately test incoming raw materials, including identity testing of each shipment of each component lot for ethanol, glycerin, or propylene glycol. The firm accepted the at-risk components based on their suppliers’ certificate of analysis (COA).
The company also lacked a stability testing program to support the expiration date of drug products. The FDA said the company did not perform any stability studies for your OTC hand sanitizer and antibacterial hand soap drug products to support their assigned expiration dates.
BEO Pharma lambasted for failure to test components
Another company, BEO Pharmaceuticals Inc. of Brooksville, FL, was also cited for failing to test incoming components used in its OTC liquid drug products. The company makes shampoos, hair serums, and skin lighteners.
The company failed to adequately test each lot of active pharmaceutical ingredient (API) for identity prior to use in your OTC drug products and relied on their suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.
The company also failed to adequately test each shipment or lot for components contaminated with high-risk diethylene glycol (DEG) or ethylene glycol (EG).
FDA also warned the company for failing to demonstrate that its microbiological test methods could ensure the product conformed to “appropriate standards of identity, strength, quality, and purity.”
Lastly, the company was faulted for failing to retain reserve samples of incoming raw materials, including APIs and high-risk components, in accordance with their written procedures.
Compounding pharmacy cited for unsanitary conditions
Drug compounding pharmacy Empower Pharmacy, based in Houston, TX, was cited for making drug under unsanitary conditions and failing to produce drugs in a sterile environment.
During the inspection, FDA “noted serious deficiencies in your practices for producing drug products, which put patients at risk.”
FDA investigators found that drug products intended to be sterile were prepared under insanitary conditions, “Whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA.”
The firm failed to perform routine environmental monitoring, and media fills were not performed under challenging or stressful conditions. FDA said that “there is a lack of assurance that your firm can aseptically produce drug products within your facility.”
The firm also failed to sterilize equipment located in the ISO 5 area. For example, the firm did not sterilize the stopper sorting bowl, supply hopper, and insertion station that come into contact with stoppers used to produce injectable drug products.
Empower was previously warned by FDA in a similar letter issued in 2021.
All of the companies were given 15 days to respond to the warning letters.
Amazon, Cosco, Dyno, BEO Pharmaceuticals, Empower
Filed under: General Problems
Wow! Hard to believe that Amazon would risk our health and lives.
Wow. Between this, the American Banker owned company Takeda (who quietly bought adderall from Shire right before the pandemic – biggest shareholders being Blackrock) I guess Billionaires will be in control of our medicines too. And Im sorry, …Letters? Why werent the factories raided? We are in the era of zero accountability or consequence for the elite class, who criminally withhold information from the public. When everyone realizes whats going on, by then its too late. What do we do?