FDA Issues Warning Letters to Manufacturers of OTC Products

The US Food and Drug Administration (FDA) has issued several Warning Letters to device and OTC product manufacturers for failure to test components among other violations. 

Aruba Aloe Balm NV

The FDA issued a warning letter to Aruba Aloe Balm NV in Oranjestad, Netherlands, for the following observed violations. The FDA also placed an Import Alert 66-40 on the firm on April 15, 2024.

• 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.
• 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, before release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary.

Ostar Beauty Sci-Tech

The FDA issued a warning letter to Ostar Beauty Sci-Tech in Beijing, China, for marketing products in the US without marketing approval. 
 
According to the FDA, the marketed products are devices because they are intended for use in diagnosing a disease or other condition or for use in curing, mitigating, treating, or preventing a disease, or are intended to affect the structure or function of the body. 
 
The following products violate the Federal Food, Drug, and Cosmetic Act:

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

Westwood Laboratories 

Following an inspection of Westwood Laboratories’ Azusa, CA facility, the FDA issued a Warning Letter including:

• 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 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 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.

Seatex

The FDA inspected Seatex’s Rosenberg, TX facility and issued a Warning Letter including:
 

• Failure to establish and follow adequate written procedures for cleaning and maintenance of equipment.
• Failure to thoroughly investigate unexplained discrepancies 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 comply with CGMP and meet established specifications for identity, strength, quality, and purity.

 
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