Company
JapanHOYA Corporation PENTAX Miyagi Factory, Kurihara, Japan – FDA Inspections
Inspection records and compliance data for HOYA Corporation PENTAX Miyagi Factory in Kurihara. 5 FDA inspections on record, 2 Form 483s, last inspected August 03, 2023.
Company Profile
This profile covers HOYA Corporation PENTAX Miyagi Factory based in Kurihara, Japan.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected December 16, 2010. Last inspected August 3, 2023.
Most cited issue areas
- Change records, content1 inspection
- Contamination control, Lack of or inadequate procedures1 inspection
- DHR content1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 3, 2023 | Not classified | Medical Devices & Rad Health | 1214325 |
| September 4, 2018 | Not classified | Medical Devices & Rad Health | 1124077 |
| April 24, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 926494 |
| November 21, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 857579 |
| December 16, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 705556 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
HOYA Corporation PENTAX Miyagi Factory
FEI Number
3003782610
Address
30-2, Tsukidate, Kurihara, Japan
Country
Japan
ID: 581745ee-6ba6-4267-9528-b88f8c68388b