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FDA Inspection
•Sun Capsule Corporation•February 1, 2018

Sun Capsule Corporation – FDA Inspection, Feb 1, 2018

Record Details

This FDA Inspection record concerns Sun Capsule Corporation, with an inspection on February 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company
Sun Capsule Corporation
Inspection Date
February 1, 2018
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • John A. Sciacchitano (Company Rep)
View Company Profile

ID · c9ff4e7a-86ef-4564-92fb-a9c8a8870113

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1039330
FDA center
Medical Devices & Rad Health
Project area
Radiation Control and Health Safety Act
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 803.17Lack of Written MDR Procedures
  2. 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

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