API issues served as a highlight for one of two Warning Letters issued last week. That one was issued to a drug product manufacturer following a March inspection. The second Warning Letter was sent to a compounding pharmacy.

Drug Warning and Untitled Letters

RLC Labs Inc

RLC Labs Inc (Phoenix, AZ) received a Warning Letter on October 9, 2020, based on the outcome of an inspection ending March 5, 2020. FDA deemed the firm’s products adulterated as the firm failed to register appropriately with the agency. FDA also encouraged the firm to hire a qualified GMP consultant(s) to assist them in coming into compliance with GMPs. Their WP Thyroid and Nature-Thyroid products are also deemed misbranded because they do not conform to published compendial standards. These products are also considered biological products. Deficiencies identified during the inspection include but are not limited to:

  • The firm’s Quality Unit did not review and approve written procedures for production and process control. The manufacturing processes have not been validated. Critical equipment was not qualified. Further, of the ten samples collected during the inspection, six of them were sub-potent for at least one or two active ingredients. Of particular concern is the narrow therapeutic range for these drugs.
  • No stability data have been generated for the current product with API from the current API supplier. 
  • There is no specification for API and individual API lots are not tested to ensure they meet specifications prior to being blended into a larger API lot.
  • The Quality Unit failed to ensure the firm had adequate procedures and did not provide adequate oversight of manufacturing activities. Further, the Quality Unit was not aware of complaint spreadsheets being maintained outside the Quality Unit, and, therefore, these complaints were not investigated by the Quality Unit. 

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

Medoz Pharmacy of Polk Inc (Davenport, FL) received a Warning Letter on September 25, 2020, based on an inspection conducted on August 9, 2019.  The firm has ceased sterile compounding and given up their Florida Department of Health Sterile compounding permit.

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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

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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

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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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