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FDA Inspection
•EPS Bio Technology Corp.•January 15, 2026

EPS Bio Technology Corp. – FDA Inspection, Jan 15, 2026

Record Details

This FDA Inspection record concerns EPS Bio Technology Corp., with an inspection on January 15, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
EPS Bio Technology Corp.
Inspection Date
January 15, 2026
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • John A. Sciacchitano (Company Rep)
View Company Profile

ID · bd75facd-afdb-491e-a6a0-7265abac84a8

Inspection Facts

Inspection number
1299020
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 803.17Lack of Written MDR Procedures
  2. 21 CFR 820.100(a)Lack of or inadequate procedures
  3. 21 CFR 820.40Lack of procedures, or not maintained

Full citation text and observation details available on the Dashboard.

Other FDA inspections of EPS Bio Technology Corp.

4
DateClassificationOfficeProject area
October 26, 2023VAICenter for Devices and Radiological HealthCompliance: Devices
January 8, 2020VAICenter for Devices and Radiological HealthCompliance: Devices
July 26, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
June 21, 2012OAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for EPS Bio Technology Corp.
  • FDA Inspection 1227391 - 2023-10-26
  • FDA Inspection 1116987 - 2020-01-08
  • FDA Inspection 845943 - 2013-07-26
  • FDA Inspection 789179 - 2012-06-21

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