FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution

FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution

The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide. The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death. Continue reading.

FDA Warning Letter on Data Integrity

 

The integrity of data is currently in the focus of international authorities In particular the US FDA issued serious violations in Warning Letters to the companies concerned. Read more about the current complaints in a Warning Letter issued to the API manufacturer VUAB Pharma.

http://www.gmp-compliance.org/enews_04898_FDA-Warning-Letter-on-Data-Integrity_9363,9267,Z-COVM_n.html

For authorities the integrity of data is an essential quality attribute in the manufacture of pharmaceutical products. After some serious deviations international authorities have moved the topic into the centre of their interest. In particular the US FDA issued serious violations in Warning Letters to the companies concerned.

In a current letter to the API manufacturer VUAB Pharma in the Czech Republic the inspector and the authority criticised multiple aspects with regard to “failure to prevent unauthorized access or change to data and to provide controls preventing data omissions”:

  • ‘The firm did not retain complete raw data from testing performed to assure the quality of API. The inspector revealed the firm did not properly maintain a back-up of HPLC chromatograms that form the basis of the product release decisions. The inspector revealed as well discrepancies between the printed chromatograms and the OQ protocol for the HPLC system, which is intended to demonstrate correct operation of the system (e.g. injection sequences and values to calculate relative standard deviation’
  • ‘The quality unit was unable to retrieve the original electronic raw data because back-up discs were unreadable. The quality unit stated that back-up discs have been unreadable since at least 2013’
  • ‘The inspector criticised that the firm does not have proper controls in place to prevent unauthorized manipulation of labs raw electronic data. The HPLC systems did not have access controls to prevent alteration or deletion of data. The HPLC software lacked an audit trail recording any changes to the data, including: previous entries, who made changes, and when changes were made’
  • ‘The laboratory employees shared a common log-in and password to access the system’
  • ‘The firm response stated they are qualifying a new HPLC system which allows operator-specific passwords and has audit trail and back-up functions. The firm will implement as well a new electronic back-up system. FDA stated that the response lacks sufficient detail about systems and controls. Simply activating audit trail functions and instituting password controls is inadequate.’
  • ‘The firm failed to review historical data to ensure the quality of the products distributed to the US market’

In response to this list of deficiencies the FDA now expects the affected company to provide a comprehensive corrective action plan to the following points within 15 working days:

  • ‘Information regarding changes in the reliability of the IT infrastructure, including improved IT systems, systems  validation, revised  procedures and retraining of employees’
  • ‘Procedures regarding passwords used to access the analytical instruments. All access levels for  computerised systems should be clearly defined and documented in a written procedure’
  • ‘A detailed summary of the steps  taken to train the personnel on the proper use of computerised  systems’

Here will find the complete Warning Letter to VUAB Pharmaceuticals from 27 May 2015.

 

 

 

 

 

Here you can find more GMP-news on the topic of data integrity:

US FDA issued a Warning Letter to the company Hikma Pharmaceuticals

 

Warning Letter: Deficiencies in Visual Inspection
In October 2014, the US FDA issued a Warning Letter to the company Hikma Pharmaceuticals justified by deficiencies in the visual inspection of vials. Read more here.

In October 2014, the US FDA issued a Warning Letter to the company Hikma Pharmaceuticals because of deficiencies in the visual inspection of vials and environmental monitoring.

Already in a Warning Letter issued in 2011, a deficiency in the visual inspection was noted as the detection and evaluation of particulate matter failed to be sufficient. Now, the current complaint in the area of visual control explicitly refers to the qualification of staff for the performance of the manual visual inspection. Here, the FDA inspectors noticed that visible markings were present on the qualifcation test sets which enabled operators for visual inspection to recognize – thanks to these markings – vials with particles. The qualification of staff has been thus completely questioned and therefore also the qualification of the whole visible inspection. According to the FDA, an assessment of the batches reviewed and released to the market by non-qualified personnel was missing in the written reply to this complaint.

Source: Warning Letter issued to the company Hikma Pharmaceuticals.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm420960.htm

 

 

 

 

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 


DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO …..FOR BLOG HOME CLICK HERE

Join me on Linkedin

View Anthony Melvin Crasto Ph.D's profile on LinkedIn

Join me on Facebook FACEBOOK

Join me on twitterFollow amcrasto on Twitter

Join me on google plus Googleplus

 amcrasto@gmail.com