FacilityLedger

Drug establishmentActive, Registered FY2026Official Action Indicated

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.

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.
TerminatedView source data ›
Jul 23, 2021 Class II
SubPotent: Out of Specification
TerminatedView source data ›

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 in FDA source data ›

Inspection history

Inspections on file
Mar 31, 2026 · Voluntary Action Indicated (VAI)
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 · No Action Indicated (NAI)
Apr 20, 2011 · Voluntary Action Indicated (VAI)
Oct 21, 2010 · Voluntary Action Indicated (VAI)
Form 483 observations
Mar 31, 2026, 2 observations: Cleaning / Sanitizing / Maintenance; Scientifically sound laboratory controls
Dec 1, 2017, 2 observations: Control procedures to monitor and validate performance; Failure to meet specifications
Dec 9, 2015, 1 observation: Cleaning / Sanitizing / Maintenance
Oct 18, 2011, 8 observations: Training , Education , Experience overall; Lab controls established, including changes; Written procedures not established/followed
Jul 5, 2011, 2 observations: Microbiological Contamination Exam; Sample size - test intervals
Apr 20, 2011, 2 observations: SOPs not followed / documented; Investigations of discrepancies, failures

FDA record timeline

FDA inspection
VAI classification
Form 483
2 observations
FDA inspection
NAI classification
Recall
Class II — cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Source ›
Recall
Class II — SubPotent: Out of Specification
Source ›
FDA inspection
OAI classification
FDA inspection
VAI classification
Form 483
2 observations
FDA inspection
VAI classification
Form 483
1 observation
FDA inspection
VAI classification
FDA inspection
NAI classification
FDA inspection
VAI classification
Form 483
8 observations
FDA inspection
VAI classification
Form 483
2 observations

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

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?

FDA has not posted a warning letter for Professional Disposables International, Inc.. FDA publishes only a subset of enforcement records, so this is not a guarantee.

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 2026-08-22

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