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[March 2024] The 2024 Compliance Issue: Addressing the Top-Cited CFRs to Pharma and Device Firms + Warning Letter Breakdown

We take a close look at most frequently cited CFRs to drug and device firms throughout FY2023 and break down a recent warning letter.

Welcome to Insider issue #23.

And a very warm welcome to the 421 new life science professionals who joined last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here.

In this year’s "compliance issue," we offer insights from the field to ensure GMP compliance in the most frequently cited CFRs for the fiscal year 2023, covering both the pharmaceutical and medical device industries. (Take a look at last year’s compliance issue here.)

For the pharmaceutical sector, we concentrate on the responsibilities of the Quality Control Unit, general laboratory control requirements, and production record review. In the medical device industry, we emphasize the significance of CAPA procedures, complaint procedures, and more.

Here’s a quick top-line look at the FY2023 numbers in each space, as gathered from the FDA’s Data Dashboard:

Drug GMP:

  1. 21 CFR 211.192 - Recordkeeping - 98 citations

  2. 21 CFR 211.22(d) - Quality Control Unit Responsibilities - 93 citations

  3. 21 CFR 211.100(a) - Production and Process Controls - 60 citations

  4. 21 CFR 211.160(b) - Laboratory Controls - 48 citations

  5. 21 CFR 211.68(b) - Equipment Cleaning and Maintenance - 47 citations

Device GMP:

  1. 21 CFR 820.100(a): Corrective and Preventive Action - 190 citations

  2. 21 CFR 820.198(a): Complaint Handling Procedures - 164 citations

  3. 21 CFR 820.184: Device History Record (DHR) Procedures - 85 citations

  4. 21 CFR 820.22: Quality Audit Procedures - 84 citations

  5. 21 CFR 820.90(a): Nonconforming Product Control - 83 citations

Our aim here is to help you identify potential gaps in your processes and offer valuable tips to reinforce your compliance efforts by examining these commonly cited regulations.

If you need third-party compliance assistance, talk to us about auditing, mock inspection, and remediation support. Every day, we help firms detect, articulate, and fix compliance issues in all of these areas.

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