FDA Warning

REJIMUS is a preeminent regulatory consulting firm that helps companies globally in the Homeopathic, Food and Dietary Supplement industries improve and ensure the overall quality of their products and ingredients while in compliance with the applicable cGMP regulations.

We specialize in responding to FDA Warning Letters, FDA Compliance ConsultingQuality System OptimizationSocial Media MonitoringDue Diligence, NDI and GRAS Notifications and Business Resource Services. Whether you are a start-up company focused on getting your first product to market and need to implement a quality system from scratch or you are a large established organization that needs to optimize and reduce risks and operating costs in regulatory and quality, we can enable you to achieve your goals efficiently.

2019 Warning Letters

Per the FDA website, an FDA Warning Letter is defined as:

“…a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.”

Key areas of FDA Compliance Consulting:

Support for a FDA Warning Letter
FDA Consulting (for inspections)

Form 483 support and correcting a 483 observation
FDA warning letter response and corrective action planning
FTC warning letters response and corrective action planning
Consent Decree support
GMP consulting (Dietary Supplement Good Manufacturing Practices)
Best Compliance Practices
Regulatory consulting
SOP reviews, writing and optimization
Ingredient specifications
Product specifications
Regulatory management consulting
Dietary supplement regulations
Homeopathic regulations
Guidance for 21 CFR Part 111, Part 110, Part 101 and Part 117 (FSMA)

Form 483 Observations

We provide consulting for FTC actions, FDA Inspection, Form 483’s and Warning Letter responses as well as GMP compliance planning for 21 CFR Part 111, 110 and 101, as well as budgeting and guidance for restructuring of quality and regulatory operations. Whether we take the lead support of an FDA inspection to ensure future compliance including the hand-on writing of standard operating procedures (SOPs) and specifications, or close out investigations and adverse events, we have the scalability to meet the most demanding of deadlines.

NEED SUPPORT?

Our team would be more than happy to assist you with your company’s needs!