Inspection Featured Articles

  1. Trends In FDA FY2023 Inspection-Based Warning Letters 2/13/2024

    The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.

  2. FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities 12/5/2023

    In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.

  3. How CCIT Helps CDMOs Fulfill Their Commitment To Quality 10/3/2023

    A lack of knowledge of container closure integrity testing (CCIT) could put a CDMO at a disadvantage compared to competitors, so it is critical to have a thorough understanding of CCIT.

  4. Choosing The Right Primary Container And Troubleshooting Issues 8/25/2023

    Selecting the right primary container for an injectable drug product is critical. Discover how to identify relevant testing to de-risk your product development – and quickly uncover causes of failures.

  5. 8 Benefits Of Vision Inspection In Manufacturing 8/7/2023

    Manufacturing requires a high level of precision and accuracy to ensure product safety and efficacy. Here, we explore eight benefits that vision inspection brings to the world of manufacturing.

  6. Breeze Through Surprise Audits — Take These 5 Actions Now 6/8/2023

    Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.

  7. Transformative Shifts In Medical Device Package Quality Testing 5/30/2023

    While the medical device industry continues to evolve to accommodate lifesaving therapies, advancements in deterministic testing technologies ensure medical device packaging integrity and sterile delivery to the patient.

  8. Inspection Technologies For Tablets And Capsules Packaging 3/28/2023

    Inspection technologies play a crucial role in ensuring the safety, quality, and reliability of tablet and capsule packaging. Explore package integrity testing methods proven to be accurate and efficient.

  9. Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny 3/27/2023

    We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.

  10. Automated Inspection Of Pre-Filled Syringes And Biologics 3/8/2023

    Container closure integrity (CCI) test methods aim to find manufacturing errors and mitigate risk to patient safety. Here, we delve deeper into the CCI testing of biologics and effective test methods.