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Medical device companies that market their products in the United States will eventually undergo an inspection by the FDA to determine their compliance with the FDA QSR. At the conclusion of such an inspection, the inspector may issue an FDA Form 483 in the event they observe any conditions during the inspection that are in violation of the Food Drug and Cosmetic Act. FDA investigators are trained to provide a list of observations where each item is clear, specific and significant.
FDA Form 483 is shared and discussed with the medical device company's management immediately at the conclusion of the inspection, ensuring that each observation is clearly understood by the medical device company and the investigator. The most common observations that appear on FDA Form 483 are:
Medical device companies can implement an FDA QSR-compliant quality management system (QMS) to avoid receiving an FDA Form 483 following an inspection.
FDA Form 483 is issued immediately following a Factory Inspection and reviewed with the medical device company's management team. The contents of Form 483 do not represent an exhaustive list of deviations from law and regulation - they are limited in scope to only things that the FDA investigator observed during the inspection. Medical device companies have 15 days from the date of receipt to submit a written response to Form 483.
FDA does issue warning letters to some medical device companies following an FDA inspection, but these are reserved for major cases of noncompliance that were noted in previous inspections and mentioned in Form 483s, but not adequately resolved by the company. Warning letters place specific requirements on the medical device company to resolve an observed compliance issue. These letters are also made available to the public on the FDA website.
FDA warning letters are an escalation of Form 483. When a medical device company receives a Form 483 with observations of noncompliance, it needs to respond aggressively to correct the issue in order to avoid a warning letter.
FDA 483 observations warrant an aggressive and immediate response to avoid a follow-up warning letter from FDA. Medical device companies should acknowledge each separate observation in their responses, indicating:
In an FDA investigation, your medical device facility will be audited for compliance with each major aspect of the FDA QSR: Production & Process Controls, Management Controls, Design Controls and Document Controls. Data released by FDA demonstrates the key problem areas for QSR compliance that result in Form 483 observations are design controls, CAPA, complaint files, nonconforming product, device acceptance activities, process validation and production & process controls.
Greenlight Guru's eQMS software is purpose-built to help medical device companies prepare for upcoming audits through satisfying the documentation and quality requirements of the FDA and avoid Form 483 observations. With Greenlight Guru, medical device companies can establish and maintain effective design controls and CAPA that meet the FDA QSR requirements, establish and maintain SOPs that define manufacturing protocols, and better manage their nonconformance issues and acceptance activities.
Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your quality processes with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →