Quality Assurance

Compliance

Quality Is Your Brand’s Reputation

In the food, supplement, and cosmetic industries, quality is everything. One mistake, one overlooked quality control measure, and your brand is at risk. Whether it’s an FDA warning letter, a product recall, or a consumer lawsuit, the cost of poor quality can be devastating—and it can happen to anyone.

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AMSRA Consulting ensures your product is consistently safe, effective, and fully compliant with the FDA’s Current Good Manufacturing Practices (cGMPs). Our team of experts is here to make sure your business is always prepared, from raw materials to finished goods.

Quality Assurance Isn’t Optional—It’s Essential

Your product’s quality directly impacts your business’s reputation and bottom line. Here's how we protect your brand:

Failure to Meet cGMP Can Lead to Product Recalls and Legal Risks

Non-compliance with FDA cGMPs can result in product recalls, legal liabilities, and permanent damage to your brand’s credibility. We make cGMP compliance easy.

Our team implements and reviews 21 CFR 110, 111, 117, and Sec 606 FD&C Act cGMPs, ensuring your entire production process meets FDA requirements. We also prepare your business for FDA and third-party audits, so you’re ready for any inspection that comes your way

Your Quality Systems Could Be More Efficient

Without a solid quality management system, your brand risks inefficiencies, delayed product releases, and costly mistakes. We develop and implement custom quality systems for your business.

From SOP creation to CAPA implementation, we ensure your systems are robust, efficient, and aligned with FDA expectations. We also handle complaint investigations and deviation management, so your operations stay lean and legally compliant.

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Inadequate Supplier Management Can Cause Supply Chain Disruptions

Your suppliers are a direct extension of your quality control process. Without proper vendor audits, you risk poor quality products that don’t meet regulatory standards.

We manage your supplier risk with thorough vendor audits and compliance verification, ensuring every supplier meets the highest standards. From supplier agreements to Foreign Supplier Verification Program (FSVP) support, we cover all the bases, so your supply chain runs smoothly and stays compliant.

How We Strengthen Your Quality Assurance Program

With over a decade of experience, we take the guesswork out of compliance by providing expert guidance and tailored services.

cGMP Compliance & Audit Readiness

Implementation & review of 21 CFR 110, 111, 117, and Sec 606 FD&C Act cGMPs
FDA & third-party audit preparation (NSF, USP, etc.)
Internal QA audits & gap assessments

Our first step is ensuring your business is audit-ready. We implement FDA-approved cGMP systems, prepare you for FDA and third-party audits (NSF, USP, etc.), and conduct internal QA audits to identify and fix any gaps

Supplier Qualification & Risk Management

Vendor audits & compliance verification
Supplier agreements & COA/COC verification
Foreign Supplier Verification Program (FSVP) support

We manage your vendor relationships to ensure compliance and mitigate risk. From conducting vendor audits to COA/COC verification, we ensure your suppliers meet U.S. food safety standards and quality expectations.

Quality Systems Development

SOP creation & QA documentation setup
CAPA (Corrective and Preventive Action) implementation
Complaint handling & deviation investigations

We build and maintain quality systems that ensure ongoing compliance and operational efficiency. We’ll streamline your quality management practices, keeping your production process smooth, effective, and legally sound.

Testing & Product Release Oversight

Specification development & product testing requirements
Microbial, heavy metal, and contaminant testing guidance
Label claim verification & stability studies

Our experts oversee product testing, ensuring everything from microbial testing to heavy metal analysis is performed correctly. We guide you through label claim verification and stability studies, making sure your product is market-ready and meets all regulatory requirements.

Why AMSRA Consulting Is Your Best Partner for Quality Assurance

Proven Expertise

With over 10 years of experience, AMSRA Consulting is trusted by industry leaders for FDA compliance and quality assurance.

Comprehensive Solutions

We provide end-to-end support for your quality assurance needs—audit readiness, vendor management, system development, and more.

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Fast, Reliable, and Efficient

We ensure your compliance process is as quick and efficient as possible—without compromising on quality.

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20 Years of Industry Expertise

Ready to Strengthen Your Quality Assurance Program?

Poor quality control isn’t just a risk—it’s a threat to your business. Let us help you avoid compliance issues and make your quality assurance systems stronger, faster, and safer.