Common SFDA Gaps & How You Can Fix Them

In Saudi Arabia, SFDA is responsible for overseeing the compliance of pharmaceuticals, food, cosmetics, and medical devices with national standards. Businesses that operate in these sectors are obliged to comply with these regulations not just as a legal requirement but for market trust and product safety. 

Despite this, many companies face challenges during inspections because they are either unaware of the full requirements or miss out on certain details. These gaps often lead to delays, penalties, or product recalls.

Understanding the most common compliance gaps and learning how to fix them can help companies avoid problems and maintain a strong reputation.

1. Lack of Proper Documentation

One of the most frequent issues found during SFDA inspections is the absence of complete and updated documentation. Many businesses keep paper records but fail to update them periodically. Some even rely on verbal confirmations rather than official written procedures. When SFDA inspectors arrive, these missing files create confusion and make it hard to prove that the company is following the law.

The best way to fix this is to set up a reliable documentation system and have proper records in place. These records include registration files, product specifications, lab reports, and quality control results. The documentation system should store and organize all files in one place, either digitally or physically. Regular internal audits should be done to make sure the documents are accurate and up to date. Assigning responsibility to specific team members can also help keep everything in order.

2. Inadequate Product Labeling

Product labeling is more than name and expiry date. Some companies fail to meet the labeling requirements because they assume international labels are acceptable. SFDA has strict rules about what must appear on the label, including text, batch numbers, manufacturing details, and warnings. 

To fix this issue, companies should review SFDA’s labeling guidelines carefully. Labels must be clear, correct, and consistent with the product’s registration information. Hiring a regulatory affairs expert or consultant can help make sure every label meets the national standards.

3. Weak Quality Management Systems (QMS)

Another major gap found during SFDA inspections is a weak or incomplete quality management system (QMS). Some businesses either do not have a structured system in place or have one that is poorly managed. For example, they might skip batch testing, ignore complaints, or fail to document changes in production processes. SFDA expects businesses to follow strict procedures for quality control, risk management, and corrective actions. This ensures that the product remains safe and consistent from production to delivery.

To address this, companies should build or improve their quality management system based on international standards like ISO 13485 for medical devices or GMP for pharmaceuticals. Regular staff training, clear procedures, and proper documentation of each step in the supply chain can make a big difference. It is also helpful to review the system at least once a year and make improvements where needed.

4. Issues with Import and Clearance Procedures

Importing regulated products into Saudi Arabia requires following the rules set by SFDA. Common issues found during SFDA inspection include failure to register a product, using expired import permits, or not providing required lab test results. These problems not only slow down business operations but can also damage the company’s reputation with customs and authorities, leading to shipment delays or rejections.

The solution is to have a team or partner who understands the import requirements. These include registration on SFDA platforms (SABER/GHAD), acquiring clearance documents, and meeting shelf-life and storage requirements. Also, all products should be approved before they are shipped. Track record of permit expiration dates and changes in clearance laws must be kept. Having a checklist for every shipment can also help reduce errors.

5. Untrained or Undertrained Staff

A lot of compliance issues arise because employees are not properly trained. This is especially true in warehouse management, product handling, and packaging. They may not know how to follow procedures, handle documents, or respond during an inspection. If employees don’t understand SFDA rules, they can unknowingly create gaps in the compliance process, and their mistakes can lead to violations.

To fix this, companies should invest in regular training programs. These should cover not just the technical side of the job but also the regulatory expectations. Training should be repeated often and adjusted whenever new rules come into effect. Staff should also be tested to make sure they understand what they learned.

6. Failure to Register Products Properly

Product registration in SFDA is one of the first and most important steps in SFDA compliance. Yet, many companies fail to complete this process in line with the set standards. Some skip key documents or use outdated forms, and some might submit incorrect information. During inspections, this leads to immediate action such as confiscation, fines, or even legal steps against the company.

The best approach is to assign this task to a qualified regulatory specialist. Double-check all documents before submission and track the registration status regularly. It is also important to respond quickly to any requests or comments from SFDA to avoid delays. If the internal team lacks the experience, partnering with a SFDA licensed consulting firm like PharmaKnowl Consulting can help in the registration process step by step and ensure everything is handled properly.

7. Non-Compliance with Local Testing Requirements

SFDA sometimes requires local lab testing for certain products, especially those that are imported. These tests check quality, safety, and compliance with national standards. Some companies either skip this step or use foreign labs that are not accepted by SFDA. This is treated as a violation because SFDA cannot confirm that the product meets safety requirements on the local level.

To avoid this, companies should work with approved local laboratories. Always confirm from SFDA whether your product needs local testing and complete it before import or distribution. Keeping the test results in your documentation system also helps during future inspections.

8. Poor Complaint Handling and Recall Processes

Every company should have an explicit approach for handling complaints and conducting recalls if needed. However, many companies either don’t have a proper system in place or ignore early warning signs. If SFDA finds out that complaints were ignored or not documented properly, this would create problem as the authority expects a quick and effective response to any reports of side effects, product failure, or safety issues. 

The fix is to set up a complaint tracking system. Make sure all customer feedback is recorded, investigated, and resolved. If a recall becomes necessary, the company should have a ready-to-use plan that includes how to contact customers, remove products from shelves, and inform the authorities. Staff should also be trained to follow this plan quickly and correctly.

9. Incomplete Storage and Distribution Records

Some companies store products in poor condition or transport them without monitoring. Others fail to document where the product went or how it was handled. SFDA wants to see that products are stored and transported in a way that keeps them safe and effective. This includes tracking temperature, humidity, and handling procedures. Missing records in this area often raises red flags during inspections.

To fix this, businesses should install monitoring systems in storage areas and transport vehicles. Regular checks and automatic alerts can help catch problems early. Distribution records should clearly show the journey of each batch, from the supplier to the end-user. This also makes recalls easier if needed.

Compliance with SFDA

Once a company addresses these common gaps, the work is not over. SFDA rules can change, and the business must be ready to adjust quickly. The key to staying compliant in the long run is to create a culture of awareness and responsibility. This means staying informed about new regulations, updating internal processes regularly, and making compliance part of daily work instead of just an occasional task.

Regular internal audits, staff training, and open communication between departments help catch problems before they become serious. Working with local consultants or compliance experts can also provide an extra layer of security. It also helps to treat SFDA inspections not as a threat but as a chance to improve systems and protect the end user.

Don’t Wait for a Wake-Up Call

Most of the common gaps in compliance come from lack of preparation or awareness, but they can be fixed with proper systems, trained staff, and ongoing efforts. Companies that take a proactive approach will find it much easier to succeed in the Saudi market and maintain strong relationships with both the regulators and customers.