December is generally a slow time when it comes to posting of FDA Warning Letters.

Nevertheless, on Dec. 3, FDA issued a Warning Letter to over-the-counter manufacturer Clientele, Inc. following a Feb. 3-7 inspection of the company’s Sunrise, FL facility.  The company’s products generally consist of skincare topicals and cosmetics.

Following the inspection, the resulting FDA form 483 featured five observations.

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Observation 1 pointed to failure to follow procedures “applicable to the quality control unit,” noting that personnel lacked the cGMP knowledge to oversee cGMP systems. 

Specific observations included:

  • Failure to ensure completion of product testing prior to distributing products
  • Lack of a supplier qualification program
  • Failure to perform stability testing and potency testing
  • Data integrity failures pertaining to batch records and raw ingredient specification records

Other observations involved laboratory controls and cleaning validation issues.

Interested in knowing more about the specific deficiencies in these areas? Want to know who inspected the site?  Test drive our Enforcement Analytics platform to get answers to those questions and more!

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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

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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

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

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