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FDA Inspection
•Supreme Screw Products•October 29, 2025

Supreme Screw Products – FDA Inspection, Oct 29, 2025

Record Details

This FDA Inspection record concerns Supreme Screw Products, with an inspection on October 29, 2025, issued by the New York District Office, covering medical devices & rad health.

Company
Supreme Screw Products
Inspection Date
October 29, 2025
Product Type
Medical Devices & Rad Health
Office
New York District Office
Person
  • Jacqueline S. Warner (Issuing Officer)
View Company Profile

ID · ea307c6d-d1d5-41e7-a7fd-a25ca97b07af

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1289318
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 820.22Quality audits - Lack of or inadequate procedures
  2. 21 CFR 820.50(a)(1)Documented evaluation
  3. 21 CFR 820.75(a)Documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Supreme Screw Products

1
DateClassificationOfficeProject area
September 6, 2023NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Supreme Screw Products
  • FDA Inspection 1220480 - 2023-09-06

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