Stem cell and allergy clinics receive CBER untitled letters

| 29 January 2021 |  By 

The US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER) has issued untitled letters to a firm marketing regenerative medicine products and to a company selling extracts for immunotherapy.
On 25 January, CBER warned the owner of a California-based company called The Body Building, Inc. for marketing “BioGenix regenerative medicine products” to treat a variety of conditions including autoimmune disease, diabetes, Parkinson’s disease, autism, and cardiovascular disease.
Among the claims cited by CBER is an assertion from The Body Building’s Facebook page that the stem cells “are highly anti inflammatory and immediately dissipate ANY PAIN [emphasis original] in the body in any area desired. They help modulate the functioning of your immune system which helps reverse the effects of auto immune disease.”
The products, which the firm claims contain “primitive undifferentiated stem cells,” do not carry a valid biologics license from FDA, notes the regulator, who referred the letter’s recipient to FDA’s suite of four guidance documents setting the policy framework for human cellular or tissue-based products.
CBER also noted that the website is advertising an exosome product, also subject to premarket review as a drug or biological product. The agency requests a response within 30 days.
In other action, CBER warned Edge Pharma, LLC, based in Colchester, VT for marketing “patient specific immunotherapy vials” and “custom mix allergy immunotherapy vials” without a biologics license. Edge Pharma had not submitted an investigational new drug application for these products; neither had the firm applied for a biologics license.
The warning letter also took issue with Edge Pharma’s characterization of itself as a “registered 503B outsourcing facility.” Wrote CBER, “Please be advised that biological products subject to licensure under section 351 of the PHS Act are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act.” Edge Pharma was referred to a January 2018 guidance on mixing, diluting or repackaging biologics outside the scope of an approved BLA, and asked to respond within 20 days.
CDER warns Texas firm for multiple violations
Separately, FDA’s Center for Drug Evaluation and Research (CDER) warned a compounding center for multiple and significant violations, including receipt of drugs from active pharmaceutical ingredient (API) suppliers who themselves have been the subject of regulatory action.
Houston-based Professional Compounding Centers of America (PCCA) garnered the letter after a week-long FDA inspection in October 2019. The heavily redacted warning letter begins by detailing the agency’s concerns about API sourcing.
“We note that an inspection of records at your facility and a review of FDA import data demonstrated that FDA has, in the past, taken regulatory action against at least 23 of your other API suppliers for the manufacture of adulterated drugs under section 501 of the FD&C Act by either listing their drugs on import alert and/or issuing them warning letters,” wrote FDA in the 27 January warning letter.
A 23-point numbered list of the warning letters issued to individual API suppliers follows, though suppliers’ identity and other key details are redacted. Enough substance was left in the list, however, to ascertain that many of the listed firms had denied FDA’s attempts to schedule inspections, and some evidently had issues found on inspection such as leaving undesirable material on the floors of the facilities, failure to investigate failed test results and failing to maintain complete data.
The letter tells PPCA to provide lot numbers and dates of distribution for all of its products, and more: “Considering that FDA has found a pattern of drug manufacturers with serious CGMP or other adulteration violations in your supply chain, in response to this letter, also provide a detailed plan to ensure you do not receive or deliver adulterated drugs in interstate commerce, in violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c).”
Other violations mentioned in the warning letter include serious problems with PCCA’s glycerin testing program, which leaves open the potential for contamination with DEG. This known glycerin contaminant has caused fatalities in glycerin-containing medicines such as cough syrup, noted FDA in the letter.
Finally, PCCA uses its name on the labels of some repackaged APIs without clearly indicating that these drugs were produced by other firms, a fact that became apparent during the October 2019 Inspection. FDA is calling for a regulatory meeting with PCCA to review the violations.


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Tags: FDA, letters, US, warning

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