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.

Redica Systems Enforcement Analytics

Get Full Access to Redica Enforcement Analytics

Enter your email address and someone will contact you shortly to answer all of your questions and get you started.

Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented on Tuesday, March 30, 2021
by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Download the slide deck and video of this informative 1-hour webinar on the common challenges small pharma firms face when developing a QMS.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
  • Recent enforcement trends involving the Quality Unit
  • Impact of the COVID-19 pandemic

Download the Special Report

APAC ad

In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

Download the Special Report

An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

Experience the Power of Redica Systems

Redica Pro Free

Sign up for your FREE account today and get instant access to:

SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.

WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject

SITES Quickly assess inspection records including dates and inspectors across all of your sites

INSPECTIONS Complete list of FDA inspections by date, company, category, and country

Get Complete Access to the Redica Systems Platform

Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform.

Discover the power of the most comprehensive database of 483s in existence.

Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.

Eliminate days of work and get your FREE personalized 483 Observation Report.