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FDA Inspection
•HOYA Corporation PENTAX Miyagi Factory•August 3, 2023

HOYA Corporation PENTAX Miyagi Factory – FDA Inspection, Aug 3, 2023

Record Details

This FDA Inspection record concerns HOYA Corporation PENTAX Miyagi Factory, with an inspection on August 3, 2023, issued by the Office of Inspections and Investigations.

Company
HOYA Corporation PENTAX Miyagi Factory
Inspection Date
August 3, 2023
Office
Office of Inspections and Investigations
Person
  • Kwong P. Lee (Company Rep)
View Company Profile

ID · 443ad41d-2d8a-47a2-b936-49fafe277557

Inspection Facts

Inspection number
1214325
FDA center
Medical Devices & Rad Health
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.40(b)Change records, content

Full citation text and observation details available on the Dashboard.

Other FDA inspections of HOYA Corporation PENTAX Miyagi Factory

4
DateClassificationOfficeProject area
September 4, 2018Not classifiedOffice of Inspections and Investigations
April 24, 2015VAICenter for Devices and Radiological HealthCompliance: Devices
November 21, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
December 16, 2010VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for HOYA Corporation PENTAX Miyagi Factory
  • FDA Inspection 1124077 - 2018-09-04
  • FDA Inspection 926494 - 2015-04-24
  • FDA Inspection 857579 - 2013-11-21
  • FDA Inspection 705556 - 2010-12-16

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