Ongoing, monthly FSMA webcast series featuring The Acheson Group. In the August 2018 session, Eric Edmunds, Food Safety Director, The Acheson Group, joined us for an update on current FSMA activities and to provide an overview of FDA Form 483. The presentation included a discussion of what happens when you receive a 483, who can see 483s, and information about the ORA FOIA Electronic Reading Room and FDA Data Dashboard. This session also covered the most common regulatory citations for Preventive Controls Rule for Human Food in 2018 at domestic facilities and current trends involving 483s, including “educate before and while we regulate” and a shift from GMPs to Preventive Control Violations. To learn more about this ongoing series, visit www.FSMAFridays.com.

1. FSMA FRIDAYS
The Latest Industry News, Updates & Trends
August 2018

2. MONTHLY INDUSTRY UPDATE
FSMA Related News
Regulation Changes & Updates
Industry Trends
Q&A with TAG
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What is FSMA Fridays?

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Agenda
HELPFUL TIPS
Informal but professional format
Ask Questions (Q&A at end)
Only panelists are displayed
Recording link will be shared
Audio issues: use call-in number
WHAT WE WILL COVER
FSMA News & Updates
FSMA Focus: FDA 483s: Trends in the Age of
FSMA
Audience Q&A

5. FSMA FRIDAYS
Presenters
Brian Sharp
VP Marketing
Eric Edmunds, JD
Food Safety Director

6. FSMA NEWS

7. FSMA FOCUS

8. FSMA FRIDAYS
What is the FDA Form 483?
 What happens when you receive a 483?
 Who can see 483s?
FDA 483s: Trends in the Age of FSMA

9. FSMA FRIDAYS
Access to 483s and inspection information
 ORA FOIA Electronic Reading Room
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperati
onsandPolicy/ORA/ORAElectronicReadingRoom/default.htm
 FDA Data Dashboard
https://www.fda.gov/AboutFDA/Transparency/InspectionComplianceDataDashb
oard/default.htmxx
FDA 483s: Trends in the Age of FSMA

10. Most common regulatory citations for Preventive Controls Rule for Human
Food in 2018 at domestic facilities
 21 CFR 117.130(a)(1): Conducting a hazard analysis
 21 CFR 117.126(a)(1): Preparing and implementing written food safety plan
 21 CFR 117.40 Equipment and utensils
 21 CFR 117.35(d) Sanitation of food-contact surfaces
 21 CFR 117.145(a) Written procedures for monitoring
 21 CFR 117.150(a)(1) Corrective action procedures
 21 CFR 117.165(a) Verification of preventive controls
FSMA FRIDAYS
FDA 483s: Trends in the Age of FSMA

11. Trends
 “Educate before and while we regulate”
 Shift from GMPs to Preventive Control Violations
 FSVP
 Produce
FSMA FRIDAYS
FDA 483s: Trends in the Age of FSMA

12. Table of complete regulatory citations:
21 CFR 117.130(a)(1): You must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific
reports, and other information, known or reasonably foreseeable hazards for each type of food manufactured, processed,
packed, or held at your facility to determine whether there are any hazards requiring a preventive control.
21 CFR 117.126(a)(1): You must prepare, or have prepared, and implement a written food safety plan.
21 CFR 117.40 Equipment and utensils.
(a)(1) All plant equipment and utensils used in manufacturing, processing, packing, or holding food must be so designed
and of such material and workmanship as to be adequately cleanable, and must be adequately maintained to protect
against allergen cross-contact and contamination.
(2) Equipment and utensils must be designed, constructed, and used appropriately to avoid the adulteration of food with
lubricants, fuel, metal fragments, contaminated water, or any other contaminants.
(3) Equipment must be installed so as to facilitate the cleaning and maintenance of the equipment and of adjacent spaces.
(4) Food-contact surfaces must be corrosion-resistant when in contact with food.
(5) Food-contact surfaces must be made of nontoxic materials and designed to withstand the environment of their intended
use and the action of food, and, if applicable, cleaning compounds, sanitizing agents, and cleaning procedures.
(6) Food-contact surfaces must be maintained to protect food from allergen cross-contact and from being contaminated by
any source, including unlawful indirect food additives.
FSMA FRIDAYS
FDA 483s: Trends in the Age of FSMA

13. Table of complete regulatory citations (continued):
21 CFR 117.40 Equipment and utensils (continued).
(b) Seams on food-contact surfaces must be smoothly bonded or maintained so as to minimize accumulation
of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms and
allergen cross-contact.
(c) Equipment that is in areas where food is manufactured, processed, packed, or held and that does not
come into contact with food must be so constructed that it can be kept in a clean and sanitary condition.
(d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated
systems, must be of a design and construction that enables them to be maintained in an appropriate clean
and sanitary condition.
(e) Each freezer and cold storage compartment used to store and hold food capable of supporting growth of
microorganisms must be fitted with an indicating thermometer, temperature measuring device, or temperature
recording device so installed as to show the temperature accurately within the compartment.
equipment must be treated in such a way that food is not contaminated with unlawful indirect food additives.
FSMA FRIDAYS
FDA 483s: Trends in the Age of FSMA

14. Table of complete regulatory citations (continued):
21 CFR 117.40 Equipment and utensils. (continued)
(f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water
activity, or other conditions that control or prevent the growth of undesirable microorganisms in food must be
accurate and precise and adequately maintained, and adequate in number for their designated uses.
(g) Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces
or equipment must be treated in such a way that food is not contaminated with unlawful indirect food
additives.
FSMA FRIDAYS
FDA 483s: Trends in the Age of FSMA

15. Table of complete regulatory citations (continued):
21 CFR 117.35(d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-contact surfaces of
equipment, must be cleaned as frequently as necessary to protect against allergen cross-contact and against contamination of
food.
21 CFR 117.145(a) Written procedures. You must establish and implement written procedures, including the frequency with
which they are to be performed, for monitoring the preventive control.
21 CFR 117.150(a)(1) You must establish and implement written corrective action procedures that must be taken if preventive
controls are not properly implemented, including procedures to address, as appropriate: (i) The presence of a pathogen or
appropriate indicator organism in a ready-to-eat product detected as a result of product testing conducted in accordance with §
117.165(a)(2); and (ii) The presence of an environmental pathogen or appropriate indicator organism detected through the
environmental monitoring conducted in accordance with § 117.165(a)(3).
21 CFR 117.165(a) Verification activities. You must verify that the preventive controls are consistently implemented and are
effectively and significantly minimizing or preventing the hazards. To do so you must conduct activities that include the following,
as appropriate to the facility, the food, and the nature of the preventive control and its role in the facility’s food safety system.
FSMA FRIDAYS
FDA 483s: Trends in the Age of FSMA

16. Q & A

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Join us next month September 28, 2018