Warning Letters / Adverse Findings
FDA Warning Letters- Punitive Inspections
- Notified Body Major Non-conformances
- Recalls
- Field corrections
- Product seizures
There are few things more disruptive than a difficult regulatory inspection. We know how to bounce back quickly and use that unhappy experience to push your company to a new level of competitiveness. We do it nearly every day by:
- Addressing the critical issues quickly with cost-efficient and well thought-out actions that even under intense scrutiny restore confidence in your operations.
- Taking a very hard look at your other processes and products to ensure that there are no undiscovered issues that will blemish future inspections.
- We will work with your team to devise cost-effective and highly efficient corrective/preventive actions with options from which you can choose.
- Not satisfied with mere compliance, we will make you more competitive.
- We will mentor your staff throughout the project to ensure that this new expertise resides in your current team.
With partners/associates located right around the world there is an expert close by who can help you.
Here are some examples of recent projects:
- A nutraceutical/supplement manufacturer who was unaware of new regulations was inspected and received 11 pages of non-compliance citations. Horizon Phoenix experts implemented important changes to product labeling, website text and marketing materials to bring them into full compliance, then drafted a complete set of policies and procedures and helped the company implement them smoothly and efficiently. Absence of past records was overcome and full compliance was established so quickly no further regulatory action was taken.
- An in-vitro diagnostic manufacturer did not have the more than 40 required product approvals. Horizon Phoenix negotiated with the regulatory authority and implemented a strategy for market access submissions and temporary approvals that allowed the manufacturer to continue offering their product for sale.
- More than 35 North American manufacturers had their quality systems registered with a notified body that lost their accreditation. These manufacturers faced losing the CE Mark through no fault of their own. Horizon Phoenix negotiated with a number of notified bodies, facilitating the transfer of their registrations with no loss of CE Marking.
- A US-based contract manufacturer expanded their operations but in doing new work they changed the basis for their regulatory compliance. Horizon Phoenix implemented the required new policies and procedures without disrupting their current operations and ensured a smooth and problem free re-inspection.
- A Canadian-based implantable device company received CE Marking certification however the notified body erred in their oversight responsibilities. When the error was discovered during a surveillance assessment the company faced several major non-conformances. Horizon Phoenix negotiated with the notified body and the competent authority to allow the company to continue to offer CE Marked product for sale, resolved the underlying compliance issues and avoided the adverse findings.
Horizon Phoenix Mentors are uniquely qualified experts who have gotten their hands dirty on everything from high volume injection molded parts to complex drug/device combinations. We understand the dynamic regulatory environment and the ever increasing challenges that come from competition in a worldwide marketplace.
Quick, efficient and effective - hallmarks of our consultation style.
The problems are fixed, confidence restored, your processes are fine tuned and your staff is more competent and confident and...