Regulatory Inspection Services

HCG  Professionals have a long (20 year) distinguished history of providing sound regulatory assistance to FDA and FSIS inspected food establishments across a wide variety of products. Whether it is an FSIS inspector conducting a Food Safety Assessment (FSA) or FDA enforcing the Food Safety Modernization Act (FSMA) regulations, HCG can help plants navigate through the complex regulatory requirements and maintain, or regain compliance with applicable food safety laws.

FSA Preparedness Services

The Food Safety & Inspection Service (FSIS) has made a commitment to conduct a Food Safety Assessment, better known as a FSA, in each establishment that processes meat or poultry products. These assessments are considered routine, based on the fact that a plant operates under a Grant of Inspection.

In addition to the normal FSA’s, FSIS also conducts FSA’s “for cause”. These “for cause” FSAs may be conducted due to a positive laboratory result for Listeria monocytogenes or E. coli O157:H7 , STEC or a company’s product being implicated in a food illness outbreak, either as a product processor or as a supplier to another company. Other factors that may result in a FSA are multiple Non-compliance Records (NRs), especially if they are linked to a common root cause, or if a processor is involved in a product recall.

If FSIS determines that a plant’s operation is not under control, the District Manager may issue a Notice of Intended Enforcement (NOIE), or if the findings are considered severe, a Notice of Suspension (NOS). Regardless, plant management will be required to present a corrective action proposal to the District Office within a limited period of time. The corrective action proposal must address the concerns that are described in the Notice. If plant management does not respond adequately, FSIS may move to withdraw the plant’s Grant of Inspection.

HCG professionals  can  assist plant management prepare for  an FSIS, FSA by reviewing plant process control programs including HACCP, SSOP and GMP programs, assessing plant pathogen control programs, reviewing plant sanitation procedures and reviewing plant records.

Regulatory Non Compliance Responses (NRs, NOIEs, NOS)

From time to time, many food manufacturing facilities experience situations of noncompliance. How they respond to those noncompliance situations can mean the difference between an issue being resolved in a timely manner or an escalation of enforcement activities that, in the worst cases, lead to an interruption of plant operations.

HCG routinely assists plants minimize the impact of a noncompliance event by helping management  adequately respond to government notices of noncompliance including Noncompliance Records NRs,  Notices of Intended Enforcement NOIEs or Notices of Suspension  NOS .

HCG Recall and Crisis Management Assistance

There can come a time when even the best run plant can find itself in a recall or crisis situation.  An ingredient supplier might change formulations or an employee may mistakenly release product under testing.   If not handled correctly, these situations can bring all plant operations under a regulatory microscope and cause uncontrollable operational or in the worst cases, legal costs.

Having a HCG professional at your side can help contain a crises and put a plant back in operation.  HCG can help investigate the cause of the crisis, suggest actions to prevent the risk of further occurrences, act as a liaison between plant management and regulatory personnel, and  assist with responding to government enforcement actions in order to return plant operations to a state of compliance.