Quality cannot be added at the end of the production process. It must be built into each step. Founders who rely on contract manufacturers benefit from a supplement facility audit checklist before signing any agreement.
A supplement facility audit combines a document review with an on-site or virtual inspection that assesses alignment with U.S. Food and Drug Administration (FDA) 21 CFR (Code of Federal Regulations ) Part 111 Current Good Manufacturing Practice (cGMP) requirements. It evaluates the quality assurance system, documentation, and daily process controls that are intended to support consistent dietary supplements.
Conducting an audit can minimize the risk of adulterated or mislabeled products, shipment delays, retailer rejections, and possible FDA or Federal Trade Commission (FTC) actions. Regular reviews can also help lower the likelihood of product recalls and maintain hygiene standards.
Use this checklist as a practical tool during any facility tour. It helps you review GMP compliance, evaluate manufacturing readiness, and document a transparent partnership.
Why Should You Audit a Manufacturing Facility?
Auditing a manufacturing facility assesses whether your partner follows good manufacturing practices, maintains effective quality assurance, and keeps written procedures that support product integrity. It gives founders visibility into production, documentation, and safety controls that help prevent compliance failures.
Regular audits demonstrate accountability and a proactive approach to regulatory compliance. Reviewing how raw materials move to finished products helps determine consistency and builds trust across the dietary supplement industry.
What Risks Do You Avoid Through Audits?
A structured supplement facility audit checklist helps identify key operational risks early and links each to its corresponding control measure. This ensures GMP compliance, maintains product integrity, and supports ongoing quality assurance across your manufacturing process.
| Risk | Control or Preventive Measure | Purpose / Impact |
|---|---|---|
| Contamination or adulteration | Sanitation SOPs (Standard Operating Procedures), pest control, and validated cleaning programs | Maintains a clean and sanitary condition within the facility and helps prevent contamination of dietary supplements. |
| Label mix-ups | Clear label issuance, reconciliation, and line-clearance records | Supports labeling accuracy during packaging to reduce errors and maintain compliance. |
| Potency or identity failures | Verified COAs (Certificates of Analysis) for raw materials and finished products, detailed specifications, and a documented stability program | Helps ensure consistent product quality, potency, and accurate product identity over time. |
| Regulatory actions | Proof of FDA registration, cGMP inspection history, and CAPA (Corrective and Preventive Action) documentation | Demonstrates ongoing compliance and accountability when addressing regulatory requirements or inspection findings. |
| Retailer rejection | Third-party certifications such as NSF (National Sanitation Foundation), UL (Underwriters Laboratories), or USP (U.S. Pharmacopeia) | Signals manufacturing reliability and provides a competitive advantage when working with retailers or distributors. |
When Should You Schedule an On-Site or Virtual Audit?
Strategic timing helps keep your manufacturing partner aligned with current good manufacturing practice standards. Conduct audits when key changes or risks arise:
- Before your first purchase order: Confirm the manufacturer employs authorized personnel and a qualified person for each operation.
- After formula, packaging, or supplier changes: Check that new components, equipment, and storage conditions meet GMP regulations.
- After major deviations or complaints: Review CAPA records and verify that corrective and preventive action items are complete.
- Annually: Perform regular internal audits to keep the quality control unit accountable and the facility in a documented state of compliance.
- Virtual audits: Use live walk-throughs of label control, raw-material quarantine, laboratory testing, and environmental monitoring points to supplement in-person reviews.
Mock audits offer a low-pressure way to identify deficiencies. A quality assurance lead should coordinate these sessions so manufacturing continues with minimal disruption.
What to Include in a Facility Audit Checklist
An effective facility audit checklist covers sanitation, equipment, people, and documentation. Each area should show that the manufacturer can perform tasks safely and keep the environment under appropriate conditions for product quality and safety.
Sanitation and Equipment Inspection Points
Focus on cleanliness and equipment. Both influence safety and regulatory standing.
Review cleaning schedules and validation records to confirm that sanitation procedures prevent contamination.
Inspect:
- Sanitation and environment: Cleaning SOPs, changeover logs, pest control records, leak prevention plans, and water systems that protect in-process materials.
- Storage conditions: Confirm that raw materials and finished products are kept under appropriate conditions to reduce contamination risk.
- Equipment: Confirm each unit is suitable for its intended use, with calibration logs, maintenance records, and clean/dirty status tags.
- Automation systems: Verify automated processes are properly validated and kept in a good state through routine maintenance and inspection.
All cleaning and maintenance activities should be fully documented. The physical plant should provide adequate space and infrastructure that support consistent manufacturing under GMP compliance.
Production Workflow and Staff Training Indicators
People and systems drive manufacturing procedures. Review the Master Manufacturing Record (MMR) and Batch Production Record (BPR) to confirm each step is followed and signed by trained staff.
Look for weight checks verified by two operators, reconciliation counts, and yield calculations. Deviation handling and CAPA tracking should be documented and accessible. Assess job training programs tied to BPR signatures and confirm re-training occurs after SOP updates.
Strong training records and role matrices indicate employees understand how to maintain product quality, safety, and consistency.
How to Evaluate Quality Control and Documentation
Reliable quality control begins with complete, verifiable documentation. A thorough review helps confirm that each batch can be traced from raw materials to shipment and that testing aligns with regulatory requirements.
Reviewing COAs, Testing Logs, and Batch Records
A compliant manufacturer keeps precise records for every batch. Check that BPRs and MMRs include reconciliation data, yield verifications, and deviation reports. Each entry should carry approval from a qualified person within the quality control unit.
Confirm that laboratory control logs indicate testing was performed according to current Good Manufacturing Practice (cGMP) guidelines. Ensure record retention meets FDA and GMP regulations.
Training and hygiene should be documented. Staff should have education, training, and experience records. Policies on clean garments and personal protective equipment (PPE) help show authorized personnel can perform tasks safely and consistently.
Signs of a Strong QA (Quality Assurance) / QC (Quality Control) Culture
A strong quality culture is visible in daily operations. Look for:
- Independent QA release authority with defined accountability.
- Scheduled internal audits and timely closure of corrective and preventive actions.
- Third-party audits that verify GMP compliance.
- Documented complaint handling and adverse-event reviews with trend analysis.
- Regular recall drills and controlled change-management systems that keep records accurate.
The FDA expects quality systems to be documented and current. When these habits are in place, the operation is more likely to remain under effective control.
Building a Compliant and Transparent Manufacturing Relationship
A well-planned audit helps reduce regulatory, financial, and brand risks. It documents whether your partner operates in alignment with FDA 21 CFR Part 111 and follows good manufacturing practices throughout production.
Maintaining that alignment requires discipline. Plan regular internal audits, keep accurate documentation, and provide ongoing GMP training. These efforts ensure that production areas remain compliant with sanitation requirements at every process step.
An audit is not a one-time event. It fosters trust between founders and manufacturers, establishing shared expectations for growth. Treat your supplement facility audit checklist as a living checklist that adapts to your business and evolving regulatory requirements.
Frequently Asked Questions
What is a facility audit in supplement manufacturing?
A facility audit is a structured review of documentation, procedures, and on-site operations that assesses GMP compliance and supports consistent product quality in dietary supplements.
How often should brands audit their manufacturer?
Many brands conduct regular internal audits at least annually, and after major formula, supplier, or facility changes.
What are GMP requirements during audits?
Auditors assess alignment with FDA 21 CFR Part 111, confirm written procedures, and evaluate whether operations are kept in a clean and sanitary condition.
Can virtual audits replace physical visits?
Virtual audits can supplement on-site work by confirming documentation and providing live video walk-throughs of laboratory testing, storage, and sanitation areas when travel is not possible.
What red flags indicate poor facility management?
Inconsistent records, expired raw materials, missing training files, and unclean equipment indicate weak GMP compliance and inadequate oversight.
References
- Code of Federal Regulations. (2025, September 29). Title 21, Part 111—Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111
- Food and Drug Administration. (2023, March 28). Corrective and preventive actions (CAPA). U.S. Department of Health and Human Services. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/corrective-and-preventive-actions-capa
- NSF International. (n.d.). Supplement and vitamin certification. https://www.nsf.org/consumer-resources/articles/supplement-vitamin-certification
- UL Solutions. (n.d.). Dietary supplement testing and compliance services. https://www.ul.com/services/dietary-supplement-testing-and-compliance-services
- United States Pharmacopeia. (n.d.). USP verified mark. https://www.usp.org/verification-services/verified-mark
