Understanding Form FDA 483 Observations
The FDA conducts inspections on Class II and Class III medical device companies either for pre-approval before products are cleared for release, impromptu routine 2-3 year checks, or “for-cause” inspection related to a specific report. These inspections can make or break the integrity of a company, especially startups that don’t take caution during their developmental stages. The inspection begins with a Form 482, as a notice of inspection, and it ends with a comprehensive Form 483 documentation given if any significant deficiencies have discovered that need to be remediated specific to the date of inspection. Factors such as inadequate corrective and preventive action (CAPA), handling, or reporting procedures are targeted during this inspection in order to determine how well the firm is complying with FDA standards. Frequently requested 483 inspections can be viewed on the FDA’s ORA Electric Reading Room to provide an idea of what can be expected from such a document. Sterling’s experience with 483 can aid in avoiding common 483 issues from the beginning of development due to our comprehensive risk and hazard expertise.
Post Inspection: Confronting Form 483
The FDA’s Form 483 documentation on a company is not publically released. Firms are allowed up to 15 days to produce a follow-up response on how they plan to address the issues presented by the inspector. Communication is key— following up with consistent updates that include your plan of action in preparation for the next inspection with a timeline of specifically how and when you will resolve issues. You are not required to respond—but just because Form 483 is a confidential document that is not made public, does not mean it should not raise alarm. What proceeds a Form 483 form is a direct warning letter to the company that is publically released and visible on any openly accessible forum, especially online. This is where flagrant violators may find their company’s progress seriously impeded by a tarnished public image among its suppliers and existing as well as potential clients.
While there are resources such as forums and templates that offer a starting point as to how to respond to 483’s online—a response is not necessarily sufficient to be considered a “good” response unless it is forwarded to both the Center for Devices and Radiological Health (CDRH) and the district office. Sterling Medical Devices has the direct qualifications from the FDA and know-how from experience handling such cases for various clients to swiftly formulate official and adequate responses as well as ensuring that they are sent to the right authority within compliant parameters, thus maintaining the company’s integrity and quality of development. The urgency of such cases should not be underestimated as the firm’s solvency depends on taking the right corrective actions in quick succession—so there is essentially no room for error—which is why firms leverage Sterling’s experience when dealing with FDA 483 notices.