# Preventive Controls Implementation Expansion in North Carolina.

> **NIH FDA U18** · NC STATE DEPT OF AGRI AND CONSUMER SERV · 2020 · $150,000

## Abstract

Project Summary/Abstract – Preventive Controls Implementation Expansion in North
Carolina
The Preventive Controls Implementation Expansion Supplement is intended to augment the
current processes and procedures in place for training, auditing, program improvement,
infrastructure development, PC inspection, compliance implementation strategies, legislative
research, rulemaking, policy analysis, outreach, joint work planning, and enforcement. The goal
for training is to continue developing a fully trained staff to conduct preventive control (PC)
inspections. This will be accomplished by hiring a training/outreach coordinator to provide risk
based inspection methodology training to the field inspection staff. The goal for the auditing is to
maintain consistency and proficiency in conducting PC inspections. This will be accomplished
by incorporating PC audits into existing Manufactured Food Regulatory Program Standard
(MFRPS) Standard 4 – Inspection Audit Program. Program Improvement and Infrastructure
development will be evaluated during the 3 year grant period to determine if enhancements are
needed to equipment and/or IT processes. The goals for PC inspection and compliance
implementation strategies are to incrementally increase contract and initiate non-contract PC
inspections. This will be accomplished by utilizing the training/outreach coordinator to teach the
field staff risk based preventive controls methodology for conducting PC inspections. The
compliance specialist would serve as an internal compliance specialist for PC inspections and
external resource for industry. A workgroup will be developed to evaluate the feasibility and
resources needed to adopt the Intentional Adulteration and Sanitary Transportation rules within
the 3 year grant period to address legislative research, rulemaking, and policy analysis section.
The goals for outreach are to educate the small and medium firms regarding the PC rule and
inspection compliance with firms under inspection. The training/outreach coordinator will provide
training on the PC rule to small and medium industry firms. The compliance specialist will
provide guidance information for industry regarding critical and chronic violations documented
on observation sheets during PC inspections. Joint workplanning and enforcement activities
between NCDA&CS FDPD and FDA are collaborative efforts and will be realized through formal
and informal communications. These communications will address contract expectations, joint
inspection planning, joint complaint follow up and other PC related situations regarding the
interest of public health safety.

## Key facts

- **NIH application ID:** 10173996
- **Project number:** 3U18FD006384-03S1
- **Recipient organization:** NC STATE DEPT OF AGRI AND CONSUMER SERV
- **Principal Investigator:** Daniel Gaines
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $150,000
- **Award type:** 3
- **Project period:** 2018-09-01 → 2021-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10173996

## Citation

> US National Institutes of Health, RePORTER application 10173996, Preventive Controls Implementation Expansion in North Carolina. (3U18FD006384-03S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10173996. Licensed CC0.

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