The US Food and Drug Administration issued several Warning Letters to manufacturers of devices and OTC products.

Ostar Beauty Sci-Tech

Ostar Beauty Sci-Tech Co. Ltd., Beijing, China, received a Warning Letter from the US Food and Drug Administration (FDA) for marketing several products in the US without marketing clearance or approval. According to FDA, the following products are in violation of the Federal Food, Drug and Cosmetic Act:

• 3 Levels Injection Insulin Gun Hyaluronic Acid Skin Injection Needle Free Pen;

• Derma Pens: Powered LED Microneedling Device Rechargeable Dermapen for Acne and Stretchmarks Removal, Power Microneedling Device Anti Backflow LCD Dermapen LED Therapy and Red LED Vibrating Photon 540 600 Needles Microneedling Derma Roller;

• LED Masks: Rechargeable Silicone Bendable Gene Biology LED Facial Light Therapy Mask, OstarBeauty Wireless 7 Color LED Light Therapy Facial Mask with Neck, LED PDT Phototherapy LED Light Beauty Machine for Face and Body Treatment;

• Personal Care Devices: Super Effective 650nm Laser Hair Growth Helmet Cap; Home Cryolipolysis Fat Freezer Weight Loss Body Shape CryoPad; Electroportation Mesotherapy Needle-Free Injection Beauty Machine.

Under the Act, these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body, according to FDA.

Aruba Aloe Balm NV

The US Food and Drug Administration issued a Warning Letter to Aruba Aloe Balm NV, Oranjestad, The Netherlands. The Letter summarized violations of Current Good Manufacturing Practices. The inspector observed several violations, including:

• Failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength and quality;

• Failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary.

• Failure to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality and purity they purport or are represented to possess.

As a result, FDA placed the firm on Import Alert 66-40 on April 15, 2024.

Seatex

After an inspection of its Rosenberg, TX facility, FDA issued a Warning Letter to Seatex, LLC, Dallas. The Warning Letter included:

• Failure to establish and follow adequate written procedures for cleaning and maintenance of equipment;

• Failure to thoroughly investigate 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;

• Failure to conduct at least one test to verify the identity of each component of a drug product. Failure to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals;

• The quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality and purity.

Westwood Laboratories

The US Food and Drug Administration issued a Warning Letter to Westwood Laboratories following an inspection at its Azusa, CA facility. In the letter, FDA cited the following violations:

• Failure to thoroughly investigate an unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;

• Failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength and quality. In addition, failure to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals.

• Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.

• Failure to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality and purity they purport or are represented to possess.