Question 1

Do Indian food exporters to USA need FDA registration?

Accepted Answer

Yes — under Section 415 of FD&C Act, any domestic or foreign facility that manufactures / processes / packs / holds food for consumption in the US must register with FDA. Indian food exporters must obtain FDA Food Facility Registration (FDA Form 3537 via FURLS) and renew biennially by 31 December of even-numbered years. Additionally, the US importer must comply with FSVP (Foreign Supplier Verification Program — Section 805).

Question 2

What is FSVP and who is responsible for it?

Accepted Answer

FSVP (Foreign Supplier Verification Program) under Section 805 of FD&C Act (added by FSMA 2011) requires the **US importer** to verify that its foreign supplier (e.g., Indian food manufacturer) complies with FDA preventive controls (21 CFR Part 117) / Produce Safety Rule (21 CFR Part 112) / other applicable FDA food safety standards. The US importer maintains FSVP records (hazard analysis, supplier verification activities, corrective actions) — FDA inspects these records during routine inspections.

Question 3

What is the FDA ANDA pathway for Indian generic drugs?

Accepted Answer

**ANDA (Abbreviated New Drug Application)** under 21 CFR Part 314 Subpart C is the FDA pathway for generic drugs (generics of an already-approved reference listed drug [RLD]). The ANDA demonstrates bioequivalence to the RLD and contains formulation, manufacturing, labelling, and bioequivalence data. Indian generic manufacturers (Sun Pharma, Cipla, Dr. Reddy's, Lupin, Aurobindo, etc.) are the largest ANDA filers globally. FDA review timeline: 10 months (standard) / 8 months (GDUFA priority).

Question 4

What is the fee for FDA ANDA filing?

Accepted Answer

For FY2024 (1 October 2023 to 30 September 2024) — GDUFA II fees: **ANDA fee $76,470 per application**; **DMF fee $76,470 per DMF** (for first-time DMF used in ANDA); **FDF facility fee $341,467 per finished dosage form facility**; **API facility fee $242,766 per API facility**. Fees are revised annually by FDA under GDUFA (Generic Drug User Fee Act). Small business waiver available for ANDA fee (small business = gross receipts ≤$3 million — applies to first ANDA).

Question 5

What is a 510(k) Premarket Notification and who needs it?

Accepted Answer

510(k) is the FDA Premarket Notification under 21 CFR Part 807 Subpart E for **Class II medical devices** — the manufacturer demonstrates that the new device is **Substantially Equivalent** to a legally-marketed predicate device. 510(k) is faster than PMA — 90-day FDA review target. Indian device manufacturers of syringes, surgical instruments, diagnostic kits, etc., typically require 510(k).

Question 6

What is FDA Pre-Approval Inspection (PAI) and how does it work for Indian facilities?

Accepted Answer

PAI is the FDA ORA's physical inspection of the manufacturing facility before approval of an ANDA / NDA / PMA / 510(k). For Indian facilities, FDA ORA inspector (from FDA's India Office at US Embassy New Delhi or flown from USA) conducts 5-10 day inspection covering cGMP (21 CFR Part 211 for drugs) or QSR (21 CFR Part 820 for devices). Observations are documented on **Form 483**; serious violations trigger **Warning Letter** and possible **Import Alert**.

Question 7

What is a US Agent and why is it mandatory for Indian exporters?

Accepted Answer

A US Agent is a US-based person or entity nominated by the foreign facility to serve as FDA's communication contact for that facility. US Agent is mandatory under 21 CFR 1.230 (food) / 21 CFR 207.21 (drugs) / 21 CFR 807.40 (devices). The US Agent must be available 24x7 for FDA communication; must forward FDA communications to the foreign facility; cannot be the FBO's own US subsidiary in some categories. I-Pro facilitates US Agent engagement via partner US FDA consulting firms.

Question 8

What is the FDA inspection cycle for Indian facilities?

Accepted Answer

FDA conducts **routine surveillance inspections** of foreign facilities every 2-3 years (higher frequency for high-risk products like sterile injectables); **for-cause inspections** triggered by adverse events / complaints / recalls. Indian facilities in FDA's "official action indicated" (OAI) classification face **Import Alert** (e.g., Import Alert 66-40 for drugs) — all future shipments detained without physical examination until the facility demonstrates compliance through re-inspection.

Fee Component	Amount (₹)	Basis / Authority
Fda Certification Statutory Fee	At actuals	Official government fee schedule (separate from professional fee)Statutory Authority
Total Government Fee	At actuals	(for default assumptions stated below)

Fda Certification

About this service

Eligibility & thresholds

What's included

Required documents

How it works

Step 1: I-Pro

Step 2: FBO

Step 3: FBO

Step 4: I-Pro

Step 5: I-Pro

Step 6: I-Pro

Step 7: FDA

Step 8: FDA

Step 9: FDA ORA

Step 10: FDA

Step 11: I-Pro

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