FDA Warning Letters Week Of 11/8/2020: Process Validation Failures

Of the two drug-related FDA Warning Letters issued last week, one, issued to a homeopathic drug manufacturer in Mexico, identified numerous validation issues concerning the manufacturing process. The other, an untitled letter, was issued to a firm marketing unapproved stem cell products.

Drug Warning and Untitled Letters

REGENERATIVE CELL INSTITUTE LLC

Regenerative Cell Institute LLC (Las Vegas, NV) received an untitled letter on November 10, 2020, based on a review of the firm’s website and social media outlets. The firm markets products made from either human adipose tissue or umbilical cord. They advertise that it treats a variety of medical conditions and diseases. FDA determined that the firm did not qualify for exemptions. FDA continues to tread gently in this area where they may, or may not, have enforcement jurisdiction.

NARTEX LABORATORIOS HOMEOPATICOS S.A. DE C.V.

Nartex Laboratorios Homeopaticos S.A. de C.V. (Mexico) received a Warning Letter on November 4, 2020, based on the outcome of an inspection ending February 28, 2020. The firm manufactures homeopathic drug products. Deficiencies include but are not limited to:

• Failure to have procedures for production and process controls, and failure to adequately validate the manufacturing process and qualify equipment used in manufacturing.  Further, during the inspection, the firm provided the FDA investigator a signed statement acknowledging that no equipment qualification or process validation was performed in support of the homeopathic drug products distributed to the United States.
• The firm did not validate the results on the supplier CoA and relied on the CoA for incoming acceptance for all attributes other than identity which was tested.

Device Warning and Untitled Letters

There were none this week.

BIMO, GCP and GLP Warning and Untitled Letters

There were none this week.

Compounding Pharmacy/Outsourcing Facilities

There were none this week.