Drug establishmentActive, Registered FY2026FDA warning letter on file

Orean Personal Care Ltd.

Orean Personal Care Ltd. is an FDA-registered drug establishment (FEI 3010999645) located in . The facility is active, registered for FY2026. Its most recent FDA inspection on record (2026-02-20) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Aug 29, 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

3010999645

Address

Unit E1 Stubs Beck Lane West 26 Industrial Estate, ,

Establishment type

Drug establishment

Products / operations

Manufacturing, Packaging

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Feb 20, 2026 · Official Action Indicated (OAI)
Mar 15, 2024 · Official Action Indicated (OAI)
Sep 8, 2017 · Voluntary Action Indicated (VAI)

Form 483 observations

Mar 15, 2024, 7 observations: Equipment Design, Size and Location; Handling and Storage to Prevent Contamination; Investigations of discrepancies, failures
Sep 8, 2017, 7 observations: Calibration/Inspection/Checking not done; Drug product sample; Valid stability test methods

Questions

Is Orean Personal Care Ltd. registered with the FDA?

Yes. Orean Personal Care Ltd. is an FDA-registered drug establishment (FEI 3010999645) in . Its current registration status is Active, Registered FY2026.

Has Orean Personal Care Ltd. received an FDA warning letter?

Yes. FDA issued a warning letter to Orean Personal Care Ltd.; the most recent is dated Aug 29, 2024 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Orean Personal Care Ltd. do?

Orean Personal Care Ltd.'s FDA-registered operations are: Manufacturing, Packaging.

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