Drug establishmentActive, Registered FY2026FDA warning letter on file

Regenerative Processing Plant, LLC

Regenerative Processing Plant, LLC is an FDA-registered drug establishment (FEI 3011320041) located in Palm, Florida. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2023-06-30) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Aug 16, 2024

CGMP/Finished Pharmaceuticals/Adulterated

Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number

3011320041

Address

34176 US Highway 19 N, Palm, Florida

Establishment type

Drug establishment

Products / operations

Analytical testing, Labeling, Manufacturing, Packaging

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Jun 30, 2023 · Official Action Indicated (OAI)
Dec 12, 2019 · No Action Indicated (NAI)
Aug 14, 2017 · No Action Indicated (NAI)
Aug 31, 2015 · No Action Indicated (NAI)

Form 483 observations

Jun 30, 2023, 15 observations: Protection from external factors; Buildings of Suitable Size, Construction, Location; Cleaning / Sanitizing / Maintenance

Questions

Is Regenerative Processing Plant, LLC registered with the FDA?

Yes. Regenerative Processing Plant, LLC is an FDA-registered drug establishment (FEI 3011320041) in Palm, Florida. Its current registration status is Active, Registered FY2026.

Has Regenerative Processing Plant, LLC received an FDA warning letter?

Yes. FDA issued a warning letter to Regenerative Processing Plant, LLC; the most recent is dated Aug 16, 2024 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Regenerative Processing Plant, LLC do?

Regenerative Processing Plant, LLC's FDA-registered operations are: Analytical testing, Labeling, Manufacturing, Packaging.

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Source: FDA public data · status as of 2026-06-06