International Business Advisory Services

FDA Los Angeles District Office and Orange County Regulatory Affairs Discussion Group
18th Annual FDA-OCRA Educational Conference *
June 3, 2015 Irvine, California

Speaker Topics Highlights
Steve Porter
- FDA Los Angeles District, Acting District Director
FDA Update Top priority:
Food Safety Modernization Act (FSMA)
“Proactive and Preventative”

1) Evaluate Hazards
2) Think what are the preventative steps: documentation of monitoring must be available for FDA inspector
3) Inspection and compliance
Foreign inspection included; plan to do 9,600 foreign inspections next 5 years
4) Import Food Safety: Foreign Suppliers must hold the same standard as US domestic suppliers so that US customers will not go for cheaper foreign made products.
5) Response: FDA has the authority to recall, if companies do not voluntarily recall. FDA will charge the costs to the Company.
6) Expenses: FDA will charge companies for :Re-inspection if no corrections made since the first inspection; Cost of recalls and subsequent inspection fees; Imports recall and re-exportation charges
7) Imports: third party certification by FDA authorized party; High-risk imports must come with 3rd party Certification
8) Importer: FDA has authority to deny entry only with presumption of suspicion and no Lab tests are needed
9) FSMA timetable: Foreign Supplier Verification: Large firms ? by 2017, medium ? 2018, small ? 2019
10) FDA strategy going forward: Specialization
Field inspectors will be specialized; no loss of time before inspections; each FDA District will be assigned a specialty area.
D. Olivier
- Certified Compliance Solutions Mike Swit, Illumina
FDA Regulation of Mobile Medical Applications Which Mobile Medical App. does FDA regulate?
FDA Guidance Mobile Medical Applications (Feb 2015)

If an App is for a medical device, then FDA regulates.
Regulatory submission of Mobile Medical Device Application
Important: User manual, Software interfaces, Cyber-security integrity
N. Dowell
-International Vitamin Corp.
Working with Dietary Supplement Contract Manufacturer (CM) Product owner must select high quality CM: owner is ultimately responsible for the products in commerce.

Regulatory challenges: Organic Product, Organic Crops, Gluten Free, Calif. Prop 65, Non-GMO etc.

Useful FDA Guidance for both CM and product owner: Contract Manufacturing Arrangement for Drugs:
Quality Agreements(PDF)
J. Joseph -Joy’s Quality Management Systems Industry Challenges to Implementation of New rules resulting from FSMA Existing: 21 CFR part 110 (1986) Food cGMP
New: 21 CFR part 117 (proposed); important: Subpart C Hazard Analysis

Applicable to both Domestic and Foreign facilities
Foreign Supplier Verification Program (FSVP)
FDA accreditation of 3rd party audits: the supplier must meet FDA standards, Audit records need to be in English
N. Guthrie
-KGK Synergize
Clinical Study Design for claim substantiation for Dietary Supplements (1) What are your desired claims?
(2) Select the right Target study population; for US clinical studies, must choose "healthy" subjects; Healthy subjects who are looking to improve some aspects of their health (3) Study endpoint should not be disease end point; use a surrogate endpoint or a marker
"Avoiding Regulatory Nightmare; Study Endpoints and Claims, Substantiation for Clinical Trials"(Free white paper)

* Please note that this is an educational conference. Both public and private presenters discussed regulatory aspects of product development. The organizers are not endorsing the presenter’s services.

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