Purac America Inc. FDA Record

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

Purac America Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Purac America Inc." is on file.

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

Latest inspection
May 13, 2026 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Purac America Inc.: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 1 inspections120242025: 1 inspections120252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202510000
202410000
202300000
202200000
202100000
202000000
201900000
201800000
201700000

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.

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Recent FDA inspections

3 inspections from Jun 19, 2024 to May 13, 2026.

DateSiteProductClassificationFEI
May 13, 2026Blair, NEFood/CosmeticsNo Action Indicated (NAI)3004348743
Apr 7, 2025Montgomery, ALFood/CosmeticsNo Action Indicated (NAI)3027260857
Jun 19, 2024Lenexa, KSFood/CosmeticsNo Action Indicated (NAI)3006246038
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

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3004348743Blair, NE1May 13, 2026
FEI 3027260857Montgomery, AL1Apr 7, 2025
FEI 3006246038Lenexa, KS1Jun 19, 2024

Purac America Inc. and the FDA: common questions

Has Purac America Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Purac 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 Purac America Inc. received an FDA Form 483?

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

When did the FDA last inspect Purac America Inc.?

The most recent FDA inspection on file ended May 13, 2026 at Blair, NE and was classified NAI. FDA has 3 inspections of Purac America Inc. on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.