Drug establishmentActive, Registered FY2026FDA warning letter on file

Professional Disposables International, Inc.

Professional Disposables International, Inc. is an FDA-registered drug establishment (FEI 2411192) located in , New York. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2026-03-31) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Jan 7, 2022

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.

Recalls (2)

Feb 4, 2022 Class II

cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Terminated

Jul 23, 2021 Class II

SubPotent: Out of Specification

Terminated

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number

2411192

Address

2 Nice Pak Park, , New York

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

Mar 31, 2026 · Voluntary Action Indicated (VAI)
Sep 19, 2025 · No Action Indicated (NAI)
Sep 19, 2025 · No Action Indicated (NAI)
Jun 23, 2021 · Official Action Indicated (OAI)
Dec 1, 2017 · Voluntary Action Indicated (VAI)
Dec 9, 2015 · Voluntary Action Indicated (VAI)
Jun 13, 2013 · Voluntary Action Indicated (VAI)
Jun 13, 2013 · No Action Indicated (NAI)
Oct 18, 2011 · Voluntary Action Indicated (VAI)
Jul 5, 2011 · Voluntary Action Indicated (VAI)
Apr 20, 2011 · Voluntary Action Indicated (VAI)
Apr 20, 2011 · No Action Indicated (NAI)

Form 483 observations

Mar 31, 2026, 2 observations: Cleaning / Sanitizing / Maintenance; Scientifically sound laboratory controls
Dec 1, 2017, 2 observations: Failure to meet specifications; Control procedures to monitor and validate performance
Dec 9, 2015, 1 observation: Cleaning / Sanitizing / Maintenance
Oct 18, 2011, 8 observations: Procedures to be written and followed; Written procedures not established/followed; Sterility/pyrogen-free testing
Jul 5, 2011, 2 observations: Sample size - test intervals; Microbiological Contamination Exam
Apr 20, 2011, 2 observations: SOPs not followed / documented; Investigations of discrepancies, failures

Questions

Is Professional Disposables International, Inc. registered with the FDA?

Yes. Professional Disposables International, Inc. is an FDA-registered drug establishment (FEI 2411192) in , New York. Its current registration status is Active, Registered FY2026.

Has Professional Disposables International, Inc. received an FDA warning letter?

Yes. FDA issued a warning letter to Professional Disposables International, Inc.; the most recent is dated Jan 7, 2022 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Professional Disposables International, Inc. do?

Professional Disposables International, Inc.'s FDA-registered operations are: Analytical testing, Labeling, Manufacturing, Packaging.

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