Top 10 Ways to get an FDA Warning Letter

It’s the question many managers ask themselves as they prepare for their upcoming audit. NSF International conducts hundreds of GMP audits at dietary supplement manufacturing facilities annually.

NSF also supports the dietary supplement industry worldwide by providing expert training on a variety of topics instrumental to understanding regulations and critical to achieving or maintaining regulatory compliance.

Here’s what our highly trained, global network of auditors found in 2016…
The cGMP systems that supplement manufacturers struggled with most last year:

  1. Ensuring that Batch Production Record follows the Master Manufacturing Record and that each step is performed appropriately.
  2. Establishing procedures to prevent pests and animals from entering the facility (installation of screens and barriers, rodent traps, insect traps, lights, etc.)
  3. Properly using equipment and utensils to protect components and dietary supplements from contamination from any source.
  4. Establishing appropriate roles and responsibilities for Quality Control Personnel.
  5. Ensuring walls, floors and ceilings are adequately cleaned and kept in good repair.
  6. Maintaining, cleaning and sanitizing all equipment, instruments, utensils and contact surfaces.
  7. Taking necessary precautions to prevent contamination, such as microbial, filth, chemical and foreign material contamination, throughout the manufacturing process.
  8. Establishing adequate precautions against contamination by microorganisms, chemicals, filth, or other extraneous materials.
  9. Establishing Supplier Qualification Procedures, including procedures for initial qualification, periodic examination (re-qualification) and disqualification.
  10. Establishing procedures and programs for maintenance of equipment.

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