Device establishmentActive, RegisteredFDA warning letter on file

Phillips Precision Inc

Phillips Precision Inc is an FDA-registered device establishment (FEI 3003387384) located in Elmwood Park, New Jersey. The facility is active, registered. Its most recent FDA inspection on record (2024-07-17) was classified NAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Dec 9, 2024
CGMP/QSR/Medical Devices/Adulterated

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
3003387384
Address
7 Paul Kohner Pl, Elmwood Park, New Jersey
Establishment type
Device establishment
Products / operations
Orthopedic, Manufacture Medical Device for Another Party (Contract Manufacturer), General, Plastic Surgery, Neurology
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Jul 17, 2024 · No Action Indicated (NAI)
Jul 17, 2024 · Official Action Indicated (OAI)
Mar 11, 2020 · No Action Indicated (NAI)
Form 483 observations
Jul 17, 2024, 8 observations: Nonconforming product, Lack of or inadequate procedures; Training - Lack of or inadequate procedures; Lack of or inadequate procedures

FDA record timeline

Warning letter
CGMP/QSR/Medical Devices/Adulterated
Source ›
FDA inspection
NAI classification
FDA inspection
OAI classification
Form 483
8 observations
FDA inspection
NAI classification

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

Questions

Is Phillips Precision Inc registered with the FDA?

Yes. Phillips Precision Inc is an FDA-registered device establishment (FEI 3003387384) in Elmwood Park, New Jersey. Its current registration status is Active, Registered.

Has Phillips Precision Inc received an FDA warning letter?

Yes. FDA issued a warning letter to Phillips Precision Inc; the most recent is dated Dec 9, 2024 (CGMP/QSR/Medical Devices/Adulterated).

What does Phillips Precision Inc do?

Phillips Precision Inc's FDA-registered operations are: Orthopedic, Manufacture Medical Device for Another Party (Contract Manufacturer), General, Plastic Surgery, Neurology.

Related facilities

Source: FDA public data · status as of 2026-08-22

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