FDA Warning Letters Week of 08/09/20: OTCs Lack Identity Tests & Unapproved HTC/P

Warning letter enforcement was sparse again this week—many warning letters to firms promoting COVID diagnostics or treatments, that continues unabated.

FDA posted one warning letter to an OTC pharmaceutical firm, but none to device, pharmacy, or outsourcing firms. CBER issued one untitled letter to a firm that markets cellular products from the umbilical cord or amniotic membranes.

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Drug Warning and Untitled Letters


TAKA USA, INC, dba Cosmetic Innovations

TAKA USA, INC, dba Cosmetic Innovations (Carrollton, TX) received a warning letter on July 29, 2020, based on the outcome of an inspection ending June 6, 2019. The firm manufactures OTC products. FDA recommends that the firm hire a GMP consultant to assist them in coming into compliance with GMPs.

The deficiencies identified include but are not limited to:

  • The OTC drug products are not tested for the identity and strength of each active ingredient prior to release and distribution. The FDA did not accept the firm’s response because it did not justify the abbreviated testing proposed; for example, no testing was proposed for impurity profiles.
  • The firm did not validate the manufacturing process and the distribution process. Further, they lack an ongoing program to ensure the process remains in a validated state. FDA did not accept the firm’s response because they did not perform a comprehensive assessment of the risks that the distributed products may pose to public health.
  • The firm did not test at least identity for incoming materials and stated that it did not test any of the components itself.
  • The firm does not have written stability procedures, a visual check was used to support expiry dating.


East West Health Solutions Inc

East West Health Solutions Inc (Salt Lake City, UT) received an untitled letter from CBER on August 11, 2020, based on a review of their website and other online sources. The firm sells cellular products derived from cord blood or amniotic membranes, claiming to treat a diverse group of illnesses and medical conditions.  FDA notes they do not meet all the requirements in 21CFR1271, nor does it qualify for any exemptions.


Device Warning and Untitled Letters

No letters were issued this week. 

Letters to Compounding Pharmacies and Outsourcing Facilities

No letters were issued this week. 

BIMO, GCP and GLP Warning and Untitled Letters

No letters were issued this week. 

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