FDA Import Alert 76-01 and the Green List, Explained
Import Alert 76-01 lets US border staff detain instruments from Pakistan without examining them. The alert's Green List names the firms excluded from that. What it means for an importer, how to check a supplier on it, and what it does not mean.
Published
By Sheikh M. Tahir, Chief Executive Officer
FDA Import Alert 76-01: the short answer
Import Alert 76-01 is the US Food and Drug Administration's import alert for detention without physical examination (DWPE) of instruments from Pakistan. Instruments from Pakistan that it covers can be held at the US border without being examined, unless the firm that made them is on the alert's Green List.
The Green List is the alert's own list of firms and their products that have met the criteria for exclusion from that detention. The Green List is a border-detention exemption, not FDA market authorization.
Why did the FDA issue Import Alert 76-01?
Because the FDA's device center (CDRH) determined that many steel instruments made in Pakistan appeared to be violative under section 501(c) of the Act, their quality appearing to fall below what they were represented to possess.
The alert cites documented analysis showing great variability in chromium content. Chromium is what stainless steel resists corrosion with, which is why the note "How the steel grades actually differ" puts the chromium figure for each grade beside its published limit.
How does a firm get on the Green List?
By showing the FDA that it makes the instruments under a quality system: the alert says documentation should be provided to the FDA confirming that the manufacturing firm is operating in accordance with Quality System Regulations.
A listing is not permanent. The alert says re-inspection audit reports may periodically be requested, and a firm that fails an audit can be removed from the Green List.
Is TGI on the Green List?
Yes. U.S. FDA Import Alert 76-01: Green List. Tahir Group of Industries is listed on the FDA Green List (firms excluded from Detention Without Physical Examination of medical instruments from Pakistan), listed since 20 January 2016 across 13 device categories.
The FDA's entry carries TGI's earlier factory address on Roras Road, Sialkot. The company has since moved; its current address is on the contact page and on every certificate it publishes.
What does the Green List not mean?
The Green List is a border-detention exemption, not FDA market authorization. It means instruments from a listed firm are excluded from detention without physical examination under this one alert, and nothing more.
For buyers requiring FDA establishment registration for a long-term partnership, TGI completes the registration under a signed agreement with the buying partner.
How can I check a supplier on the Green List myself?
Open the FDA's own Import Alert 76-01 page and search it for the firm's name. A firm on the Green List appears under the list of firms excluded from detention, with its address, the date its entry was published and the device categories it covers. The page is large and can be slow on a phone.
TGI's entry reads "Date Published : 01/20/2016" and lists 13 device categories, from 73 Anesthesiology to 90 Radiology.
Source: US Food and Drug Administration, Import Alert 76-01, the version published 11/06/2026, read on 13 November 2026 at accessdata.fda.gov.
Who confirms what my import needs?
Your customs broker, before the first order: who is the importer of record, and what the goods need to enter. The Green List answers one question at the border; it does not answer the others.
TGI's certificates, with their numbers and how to check each one at its issuer, are on the certification page.
Where the facts behind this are published
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