The US FDA has sent a warning letter to Absolutely Natural of Melbourne, FL.

FDA conducted an inspection from April 22 to 24, 2025 where it found “significant violations” of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

In the Dec. 30 letter, FDA said the company’s methods, facilities or controls for manufacturing, processing, packing or holding do not conform to CGMP. Therefore, its drug products are “adulterated” within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

The FDA reviewed the company’s May 15, 2025 response to our Form FDA 483 in detail and acknowledge receipt of subsequent correspondence.

During the inspection, FDA investigators observed specific violations including, but not limited to, the following:

“Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

“You manufacture (b)(4) over-the-counter (OTC) non-sterile drug products, including those labeled for use in (b)(4).

“You failed to conduct an adequate investigation in July 2024 when a batch of drug product failed microbiological testing due to out-of-specification (OOS) results for both total plate count and Pseudomonas aeruginosa. Although you rejected the batch, you failed to adequately assess the root cause of the microbiological contamination, and you failed to extend the investigation to additional batches that may also have been affected.

“It is necessary to conduct a thorough, well documented, and scientifically sound investigation to identify the root cause of an OOS, to evaluate all potentially affected batches, and to implement a timely and effective corrective actions and preventive actions (CAPA) plan.

“In your response, you described the following activities that you initiated after the inspection: (1) You performed a risk analysis; (2) you initiated an investigation into the OOS incident noted above; (3) you revised your OOS investigation procedure to include root-cause determination; (4) you retrained personnel on revised procedures; and (5) you conducted a retrospective review of OOS results.

“Your response is inadequate because your investigation did not adequately assess additional drug products that may have been affected by this microbiological contamination. Additionally, your response lacks sufficient details about your retrospective review of OOS results.

Cosmetics Manufactured for Distribution in the U.S.

According to the FDA letter: “In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.

“We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.”