Improving Standard Operating Procedures and Avoiding FDA 483 Letters

Standard Operating Procedures (SOPs) define the essential steps, their sequence, and the precautions necessary to formally repeat a quality performance. In other words, they are a blueprint for risk mitigation.

FDA 483s

Pharmaceutical companies must continually look to improve their SOPs, both for themselves and for their customers. In this process, the cleanroom is the clear priority, the most critical part of any pharmaceutical industrial environment. Procedures must be as pristine as the room itself, with equipment and supplies that work on optimum levels.

10,000 483 citations issued a year


There are definite consequences for not keeping up with SOPs. Here's just a few examples:

  • PharMEDium Services, LLC recalled 25,327 units of drug products, due to a lack of assurance of sterility.
  • Sun Pharmaceutical Industries, Inc. recalled 2 lots of Riomet®, due to contamination with Scopulariopsis brevicaulis,
    a fungal pathogen.
  • Bella Pharmaceuticals recalled all lots of unexpired drug products, due to a lack of sterility assurance.
  • Vital Rx, Inc. recalled all lots of compounded injectable prescription medications, due to a lack of sterility assurance.
  • Leader Brand, Major Pharmaceuticals, and Rugby Laboratories jointly issued a recall of all lots within expiry of liquid
    products manufactured by PharmaTech LLC at its facility in Davie, Florida, due to possible product contamination.
  • Hospira, Inc. recalled one lot of 25% Dextrose Injection, USP, pre-filled syringe, due to the presence of particulate matter.
  • Isomeric Pharmacy Solutions recalled all lots of sterile products within expiry, due to a lack of sterility assurance.

FDA consent decree - $300 million


Want to Know How to Make Your 
SOPs Effective?

Compliance is an opportunity, not a hurdle. Quality management should be a 
source of renewal for the industry, an inspiration for improvement. Hesitation 
to update or improve outdated manufacturing processes, methods or 
equipment will inevitably lead to monetary damages and patient risk. Check 
out our Executive Briefs below for more information on 
ways to overcome the dangers of incorrect SOPs.