Week of May 26th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This was a holiday week in the US and may explain the shortage of published items from the FDA.  Enforcement saw a single untitled letter to a stem cell facility (and 50-plus affiliates) and a warning letter to a compounding pharmacy.

 

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UNTITLED LETTER | R3 Stem Cell, LLC

R3 Stem Cell, LLC (Cave Creek, AZ) received an untitled letter from the FDA, CBER in this case, on May 28, 2019 based on the advertisements on their website for “…regenerative stem cell therapies at affiliated center or clinics throughout the United States.”

The press announcement states that more than 50 affiliate centers or clinics have also been informed of this enforcement action.  The untitled letter contains a lot of boilerplate text on why FDA is taking this action.


DRUG, COMPOUNDING PHARMACY | Rocky Mountain Pharmacy Inc.

Rocky Mountain Pharmacy Inc. (Bozeman, MT) received a warning letter on May 9, 2019 based on the outcome of an inspection ending March 13, 2018.

Deficiencies include but are not limited to:

  • Potent drug products were prepared without adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination.  Specifically, the firm utilized non-dedicated equipment and utensils to produce drug product with no assurance that its cleaning process can deactivate and remove residual drug product.
  • The firm failed to confirm that the quality of water was suitable for its intended use in the production of non-sterile drug products.  In addition, non-pharmaceutical grade components, including (b)(4) alcohol, were used in production of non-sterile drug products.
  • The firm failed to establish and follow written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
  • The firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)).
  • The firm failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use (21 CFR 211.84(d)(6)).
  • The firm failed 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 (21 CFR 211.165(a)).
  • The firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).

 

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