Compliance Solutions

FDA Inspection Readiness Programs

FDA compliance issues can be a real nightmare if not addressed in a manner that is appropriate for the situation. Sensyo Inc. Consultants have the expertise and experience you need to assist your firm in all FDA compliance situations to provide acceptable solutions to FDA problems. Our staff will work out comprehensive strategic plans and help you implement them that allow you and your staff to fully understand the situation facing your firm, how to best address the problems and the possible outcomes of each strategy. Sensyo Inc. consultants have years of experience in dealing with the FDA during problem situations.

Review and Replies to FDA 483/Warning Letters

Sensyo Inc. Consultants provide expert guidance on how to respond to all FDA 483 observations and/or Warning Letter that can be the difference between definitively addressing FDA concerns, or continuing to suffer from further regulation fall-out, such as, non-approvals, seizures, injunctions or even criminal prosecutions. Sensyo Inc. Consultants have extensive experience in reviewing these official documents, preparing a strategy for reply and assisting with the response in such a manner to provide the FDA with a reason to reevaluate the situation before taking additional regulatory action. Sensyo Inc. Consultants have prepared numerous replies to FDA 483's that have prevented the issuance of Warning Letter and replies to Warning Letters that have prevented the issuance of non-approval determinations, Injunctions, Seizures and/or Criminal Prosecutions. This service should be part of your regulatory strategies.

Assist with FDA inspections

FDA inspection could be one of the most trying times in dealing with the FDA. Knowing what to expect, trying to interpret the FDA findings and providing immediate solutions to prevent regulatory actions could be critical to the survival of a company. Sensyo Inc. Consultants have successfully navigated numerous companies through FDA inspections both domestically and international, where the consequences of an actionable inspection could prevent exportation to the US. Our staff provides a professional demeanor to the FDA visit and assists to expedite the inspection in a manner that has been proven over time.

Act as FDA Liaison

• Be available for FDA inspections at your facility. This would help in interpreting FDA requests and observations during an inspection.
• Assist in preparing correspondence to the FDA, and replies to FDA 483's.
• Obtain information under the Freedom of Information Act (F.O.I.)
• Supply regulatory updates, Federal Register announcements, and the latest news about industry events.
• Represent the company before a regulatory agency, in the district office, or in Washington, D.C.

Foreign Manufacturer's Compliance

For Foreign Drugs, API and Device Manufacturers to pass an FDA inspection has double importance:

• To be able to obtain new FDA approvals and
• To be allowed to export products to the US without interruption. Many foreign companies do not understand the FDA inspections and are left with a long list of serious observation on their FDA 483's, which results in a Warning Letter and/or non-approvable determination. The issuance of a Warning Letter could prevent future shipment to the US until the Warning Letter is rescinded. Sensyo Inc. has the expertise to assist foreign drugs, API and device manufacturers to understand the FDA inspectional strategy and to provide assurance of passing the FDA inspection. Sensyo Inc. consultants have extensive hands on experience provided on site consulting to foreign manufacturers worldwide prior to and during the FDA inspection