# FDA WARNING_LETTER - Hoya Corporation - Pentax Life Division - April 24, 2015

Source: https://www.keypedia.com/records/warning_letter/hoya-corporation-pentax-life-division/3eccb8e9-22b4-45b8-9a2a-c2a2ce5bbc91

> FDA WARNING_LETTER for Hoya Corporation - Pentax Life Division on April 24, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hoya Corporation - Pentax Life Division
- Inspection Date: 2015-04-24
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to Hoya Corporation (PENTAX Life Care Division) following inspections in April 2015 at their Japan facilities (Akishima-shi, Tokyo; Kurihara-shi, Miyagi) and Pentax of America, Inc. in Montvale, New Jersey. The inspections found that the firm's endoscopes and accessories were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include:
1.  **Failure to establish and maintain design validation procedures (21 CFR 820.30(g))**: Validation studies for ED-3670TK's EtO sterilization and cleaning/HLD IFUs used different model/series endoscopes without documented justification for applicability. EtO sterilization validation for ED-3490TK and ED-3670TK used incorrect gas concentrations. DHF lacked protocol and raw data for EtO sterilization and HLD validation reports. Reprocessing validation protocol lacked specific testing conditions (

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.keypedia.com/records/warning_letter/hoya-corporation-pentax-life-division/7c24c1a6-1fa8-420e-8461-ae2a14042912)

## Related Officers

- [Krishna Govindarajan](https://www.keypedia.com/people/krishna-govindarajan/1a658f06-8039-4873-bf3f-9f5f46d48be9)
- [Hiroshi Suzuki](https://www.keypedia.com/people/hiroshi-suzuki/1c12c5d9-f262-4705-96c1-0c732939def4)
- [Jan B. Welch](https://www.keypedia.com/people/jan-b-welch/65bfaf7c-7ce6-4c33-80bd-090efbf2eec5)
- [District Director](https://www.keypedia.com/people/diana-amador-toro/66f3f6c5-4cfe-4f40-b4d4-d24ed4618e64)
- [Christopher Burton](https://www.keypedia.com/people/christopher-burton/8f4dff9d-fa3e-47a2-bead-8b4345a36bb5)

Company: https://www.keypedia.com/companies/hoya-corporation-pentax-life-division/67c8d69c-e284-4639-bd32-f0f95911dda2

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7