The FDA inspections reveal the following violations from companies in 2020

FSVP Development 514

FDA audits follow the accredited Third-party audits. One can conclude from the FDA inspections that the Third-party audits are ineffective in assisting organizations to improve. Audits are a sampling exercise and there is an expectation that the third party audits will make companies better. For every FDA violation – there is a required reinspection. In 2022 the fees for reinspection by the FDA are as follows:
Table 2 - FSMA Fee Schedule for FY 2022
Fee Category Fee rates for FY 2022
Hourly rate if domestic travel is required $277
Hourly rate if foreign travel is required $330

Audit Outcomes

According to 21 CFR Section 1.506 more than one form of record is allowed for verification. These are as follows:

Onsite audit

  • Include audit procedures, audit dates, conclusions, corrective actions, performed by qualified auditor
    • If the food is subject to one or more FDA food safety regulations, must consider applicable FDA food safety regulations or, when applicable, may consider relevant laws and regulations of country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States o Must include review of supplier’s written food safety plan, if any, and its implementation, for the hazard being controlled
    • Conducted before importing the food and periodically thereafter
    • Must be performed by entity other than foreign supplier
    • Results of inspection can be substituted for onsite audit (inspection within 1 year of date audit would have been conducted)

Sampling and testing of the food > Include number of samples tested, type of tests conducted, dates of tests, date of test report, results, any corrective actions, testing laboratory, performed by qualified individual

  • Conducted before importing the food and periodically thereafter

Review foreign supplier’s food safety records

  • Include dates, general nature of records reviewed, conclusions, any corrective actions taken, conducted by qualified individual
  • Cannot be performed by foreign supplier
  • Conducted before importing the food and periodically thereafter

“Other” verification activity – Conduct and document or obtain documentation of other supplier verification activity Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) Regulation Records Requirements 5

  • Documentation of each activity, including description of activity, date activity conducted, findings or results, any corrective actions taken, and conducted by qualified individual
  • Conducted before importing the food and periodically thereafter

Realizing Verification

Other methods of verification are identified besides onsite audits. The current practices do not yield ongoing compliance, as evidence by the FDA violations. Audits are not making entities demonstrate compliance. The infrastructure format for managing food process flow chart is based on the traditional discipline silos, which are attempting to facilitate FSMA’s risk based requirements. The dissonance suggests an alternate format is needed for operationalizing the law. The point is – the present and traditional management tools methodology are not designed to enable ongoing compliance – especially with paper.

fsma SaaS offers harmonious technology that systematically covers all the requirements for FSMA digitally, with appropriate management controls, with the supplier’s seamless interface with the importer. Its digital intuitive flow facilitates ongoing compliance, paperlessly.

The importer can meet the verification responsibilities through the seamless interface. It is direct method for 100 % verification – rather than depend on a third party auditor results, which can be as old as one year. The information that can be presented to the customs and the FDA inspections.

fsma SaaS presents more certainty for verification outcomes rather than risking the results of a sampling exercise. Moreover, because of its design, the importer is assured of the supplier compliance.

Which is preferred? the risk of violations because of sampling which could lead to reinspection fees and the possible disruption of the supply chain or ongoing compliance?


Because of continuing FDA inspections violations – it is necessary to consider other verification options that are within the law because audit sampling is unreliable and the traditional operating methods are not conducive to producing the desirable outcomes.

Foreign entities are to be audited by accredited third party certification bodies per 21 CFR § 1.600’ Eligible entity means a foreign entity in the import supply chain of food for consumption in the United States that chooses to be subject to a food safety audit under this subpart conducted by an accredited third-party certification body. Eligible entities include foreign facilities required to be registered under subpart H of this part.

Food Safety is subject to regulatory compliance. Software is the most efficient method to effectively manage compliance. ‘fsma SaaS’ is a food safety software application.
The Principal of ‘fsma SaaS’ spent 15 years in food manufacturing. His involvement was both in production and maintenance management and his experience also included ISO Standards consulting for California state.  The experiences led to the design of food safety software. As a PCQI, his familiarity led to the design of food safety software. The mechanics of ‘fsma SaaS’ operate as a system.

 The ‘fsma SaaS’ application consists of a Cloud and two apps – Shecklist and Sheca.

‘Shecklist’ manages Hazard Analysis and Risk-Based Preventive Controls. The scheduled download is available at each process step from the cloned process.
‘Sheca’ manages the corrective actions at each process step.

The applications employ ISO standard techniques for control. The construct of ‘fsma SaaS’ enables end to end control in one software program. Layered controls and verifications enable compliance.  Operator decisions are limited to either yes or no. The software acts as a manager making logical decisions. After the operator decides yes/no, the software directs the next action. The action follows a controlled process of clauses for regulatory compliance. Paper or more than one software program cannot automate error-proofing. A gap exists if disciplines are not all-inclusive.

                                                                         LOWEST FSMA COMPLIANCE COST

  1. Suppliers and Receiving facilities see the same cloud records
  2. Auto alerts for food safety plan deviation- no riffling through records
  3. Handles information once

                                                                          FASTEST FOOD SAFETY RECORDS

  1.  Auto download and Upload of data
  2. Records from operations delivered in real-time
  3. No documentation backlog
  4. The system manages a 7-day limit for verification.

                                                                         EASIEST REGULATORY

  1. Sets final lot number in the cloud with cloned process
  2. Triggers auto corrective action
  3. Embedded training
  4. Set up for preventive controls and monitoring

The application is a QAI 'Best of the Best' award-winning technology

Let Us Maintain Your FSMA Compliance

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