FDA, GMP, USDA: Important Letters We Are Proud Of

At HerbEra, we are passionate about herbal traditions and their benefits for wellness. But we understand that passion alone isn’t enough. Gorgeous photos and loud promises are nothing if they are not backed up by efficient and reliable practices.

To prove that we consistently meet the highest standards at all production stages — from planting the seeds to delivering tinctures and captures to the shop shelf — we are ready to undergo thorough inspections.

You deserve to know exactly what you consume with herbal supplements. This is why we pursue total transparency and gladly open our doors to show what happens at each production stage.

FDA-Registered Facility: A Synonym to Transparency

What does it mean to be an FDA-registered company? 

For a business, this means to disclose key information about the company and operational process and be ready to open the doors for thorough inspections. 

FDA has the authority to inspect manufacturing facilities to verify compliance with sanitation, storage, labeling, and operational guidelines (FDA doesn't guarantee it inspects all the registered companies.)

Inspectors ensure that all production processes are done properly, the equipment and facilities are clean, the personnel are educated, and all records are kept.

If the agency discovers any risks for possible contamination caused by equipment issues or process flaws, the facility must address them. Otherwise, FDA may impose a strict penalty. 

GMP Certification: A Quality Mark

What does the “cGMP Certified” seal on HerbEra products mean? Shortly, it means that independent third-party auditors accredited for GMP certify that our company meets all current good manufacturing processes criteria.

What should a company do to achieve such a certification? After application for certification, an inspector arrives and performs a gap analysis.  They check if the facility operates the same way as it should be. 

The inspector examines the facility’s quality system:

• The manufacturing facility should have Standard Operating Procedures (SOPs) in place.

• The papers should be clear and comprehensible, so the operators can easily understand them.

• The facility should properly follow these procedures.

• The personnel should be trained on them.  

Facilities Analysis

After that, the inspector starts evaluating the facility, including the equipment and the materials. The auditor:

• inspects the floor plan,

• observes the flow of personnel,

• ensures that everything is designed to prevent cross-contamination and adulteration.

Equipment Log Review

Next, the agent inspects all equipment logs. Every tool should be:

• properly and regularly maintained,

• calibrated according to industry standards.

Personnel Review

The inspector reviews the facility personnel and verifies that all the operators have been trained properly.

Batch Production Records

After that, the auditor examines Batch Production Records (BPRs) and checks:

• the documentation,

• traceability.

Final Steps

Inspectors issue a report, where they list any violations or deficiencies. The business must take all necessary measures and resolve the issues. After that, an inspector performs another audit, and if the company has met all the requirements, it obtains a GMP certification. The document is valid for up to three years.

USDA Organic Certification: Validation of Purity

A lot of people try to choose organic products. These products are believed to be healthier than nonorganic ones, as they are grown, processed and stored without using GMOs, synthetic additives, fertilizers, or pesticides.

When we consume organic products we don’t only take care of ourselves, we also take care of our planet and nature that gifts us everything we have. We save it for future generations. 

How can we be certain that we buy real organic products? They have this beautiful USDA Organic Certification seal on the label. But what does it mean? How to achieve it? Is it enough if a company buys ingredients from a private farmer? Let’s explore how to get this hallmark of purity.

It takes five steps.

Step 1. Create an organic system plan

The company should provide a plan describing how it will comply with USDA regulations. This document should inform about:

• seed cultivation and harvesting,

• storing,

• transporting,

• substances used during the growing or handling process (there should be no synthetic additives),

• monitoring and recordkeeping systems,

• barriers preventing cross-contamination and adulteration.

Step 2. Implement this plan

Implement the organic operations and invite a certifying agent accredited by USDA to review and validate it.

Step 3. Receive inspection

An auditor must inspect on-site operational processes. These inspections differ depending on the facility. For example, for a processing facility, like HerbEra, the inspector checks:

• receiving areas,

• processing units,

• storage areas.

They inspect areas used both for organic ingredients and finished products.

Step 4. A certifying agent reviews the inspection report

The inspector makes a report that indicates any risks of contamination, potential hazards, and critical control points. They might take product samples.

A certifying agent reviews this report.

Step 5. The certifier issues a certificate

If the facility complies with the guidelines, it gets an organic certificate. In the document, there is a list of all products the company can sell as organic ones.

To maintain certification, the business should undergo inspections at least once a year.

Why You Can Trust HerbEra

At HerbEra, we strive not just to get certified, we aim to run business ethically and sustainably.

We are sure that our customers deserve full transparency, so we open our doors to third-party audits to verify that all our processes meet the strict criteria of the FDA, GMP and USDA.