Legal experts provide tips for FDA inspections

Legal experts provide tips for FDA inspections

Presented May 15, 2014

Published: Thursday, May 15, 2014

The American Herbal Products Association (AHPA) on May 15 presented tips for handling every aspect of a Food and Drug Administration (FDA) inspection--from pre-inspection preparation to interacting with on-site inspectors--and responding to observations and warning letters.

The two-hour teleseminar, "FDA Inspections & Emerging cGMP Compliance Issues for Dietary Supplements," was part of the AHPA's cGMP Compliance Series designed to help the dietary supplement industry understand and efficiently comply with current good manufacturing practice (cGMP) regulations (21 CFR 111). In part, 21 CFR 111.12(c) states, "Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person's assigned functions."

Veteran industry legal experts provided an insider's view of current cGMP enforcement landscape and AHPA staff offered a detailed analysis of data from recent inspections. 

  • Advise inspectors at the beginning that no pictures are allowed if you have a "no camera" policy at your facility;
  • You are not required to answer all questions immediately and this may allow you to frame an answer or call legal counsel or a consultant;
  • You are not required to provide information to FDA inspectors that is not required by the cGMP regulations; and
  • Listen and, as appropriate, respond to observations during the inspection rather than waiting until the inspection is over. 

AHPA Chief Information Analyst Merle Zimmermann, Ph.D., provided an analysis of 506 FDA inspections performed from 2008 to 2013. Dr. Zimmermann's analysis of the data revealed that the exact same issues identified by inspectors could result in a Form 483 or a discussion item in an Establishment Inspection Report (EIR). In some cases, a company took action to address the issue while the inspection was in progress and FDA inspectors recorded the issue as an EIR discussion item rather than a Form 483.

Justin Prochnow, Esq., of Greenberg Traurig, gave an overview of recent FDA warning letters to supplement companies which provided insight into FDA's enforcement priorities. Prochnow reminded participants that FDA warning letters are not proof of violations; they are only the FDA's opinion. He also reviewed the top ten alleged cGMP violations according to recent warning letters as followed: 

  • Obligations of Private Label Distributors 
  • Specifications 
  • Identity Testing 
  • Qualifying Suppliers 
  • Master Manufacturing 
  • Records Batch Records 
  • Quality Control 
  • Product Complaints 
  • Equipment 
  • Expiration Dating

Marc Ullman, Esq., a partner at Ullman, Shapiro & Ullman, provided tips for preparing for an FDA inspection. He recommended companies educate employees about FDA inspections and establish standard operating procedures for an inspection. He also stressed that companies should document everything because, "If it's not in writing it didn't happen."

Ashish R. Talati, Esq., a member of Amin Talati, LLC, provided tips for drafting an effective written response to an FDA Form 483. He noted that a written response is not required, but it is in the company's best interest to respond.

  • He also reviewed common pitfalls for companies to avoid, including:
  • Failing to provide documentation of corrective actions taken
  • Failing to meet stated commitments
  • Failing to keep FDA updated by providing supplemental responses as various corrective action commitment dates are met
  • Failing to ensure and document that new quality systems are being followed by the company.

AHPA teleseminar participants earned a Certificate of Completion that documents the training they received. This presentation will be available for purchase on the AHPA website in the near future.


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