Inc. Adamson Analytical Laboratories

Adamson Analytical Laboratories, Inc.
Product: finished pharmaceuticals
Date: 8/2/2016

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, 21 CFR parts 210 and 211, and significant deviations from CGMP for active pharmaceutical ingredients (API).

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

Specifically, your high performance liquid chromatography (HPLC) and gas chromatography (GC) data acquisition systems did not have sufficient controls to prevent deletion or alteration of raw data files. During the inspection, our investigators observed that your laboratory personnel use a shared password to access the HPLC (b)(4) computer system and that your GC (b)(4) computer system requires no password for access.

In addition, multiple instruments had no audit trail function to record information about each analytical test, such as:
type of injection
date and time
identity of analyst
reason for action taken (for example, modifying a record)
This is a repeat observation from our February 7, 2013, inspection. In 2013, you committed to augmenting the security of your computer systems within six months. However, based on our 2015 inspection, it appears that you have not made appropriate corrective actions such as installing audit trails and ensuring that analysts have unique user names and passwords for your computerized systems.

It is essential that your firm keep track of all changes made to your electronic data. The use of audit trails for computerized analytical instrumentation helps to ensure that all additions, deletions, or modifications of information in your electronic records are authorized. It also allows you to verify the quality and integrity of the electronic data your contract testing laboratory generates for your customers.

We acknowledge your commitment to install and configure appropriate electronic controls to ensure that access to your computerized systems and data is restricted to authorized personnel with access rights specified for each individual. However, your response is inadequate as you did not provide an action plan describing the interim security measures in place prior to your installation of electronic controls. Your response also lacked details regarding the type of electronic controls to be installed, and you did not describe how you will evaluate the effectiveness of these computerized system changes.

FDA District: Los Angeles District

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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