Home / Companies / PreGel America, Inc.

PreGel America, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · Nov 13, 2023
No warning letters matched by name

Inspections 2

0 OAI

Recalls 1

0 Class I (0%)

Warning letters 0 None on file

510(k) clearances 0 None on file

PreGel America, Inc. has 1 FDA recall, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "PreGel America, Inc." is on file.

What these totals cover: FDA records filed under the name "PreGel America, Inc." and its spelling variant "Pregel America".

Latest recall: F-2108-2019 · Class II · Aug 2, 2019
Latest inspection: Nov 13, 2023 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	1	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

PreGel America, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

PreGel America, Inc.: FDA inspections per year

Year	Inspections	Recall records
2026	0	0
2025	0	0
2024	0	0
2023	1	0
2022	0	0
2021	0	0
2020	0	0
2019	0	1
2018	0	0
2017	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Reviewing PreGel America, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check PreGel America, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Recent recalls

1 recall record on Aug 2, 2019.

Number	Class	Product	Date
F-2108-2019	Class II	PreGel Lemon 50 4.4 lb (2kg) bag, Ingredients: dextrose, citric acid, mono and diglycerides of fatty…	Aug 2, 2019

Recent FDA inspections

2 inspections from Sep 27, 2011 to Nov 13, 2023.

Date	Site	Product	Classification	FEI
Nov 13, 2023	Concord, NC	Food/Cosmetics	No Action Indicated (NAI)	3004396173
Sep 27, 2011	Concord, NC	Food/Cosmetics	No Action Indicated (NAI)	3004396173

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3004396173	Concord, NC	2	Nov 13, 2023

PreGel America, Inc. and the FDA: common questions

Has PreGel America, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "PreGel America, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has PreGel America, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "PreGel America, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect PreGel America, Inc.?

The most recent FDA inspection on file ended Nov 13, 2023 at Concord, NC and was classified NAI. FDA has 2 inspections of PreGel America, Inc. on file.

Has PreGel America, Inc. had an FDA recall?

Yes. PreGel America, Inc. has 1 FDA recall on record. The most recent started Aug 2, 2019.

Need more than this page shows? Ask about PreGel America, Inc. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.