HOYA Corporation PENTAX Lifecare Division — FDA Facility Profile
HOYA Corporation PENTAX Lifecare Division is an FDA-registered facility (FEI 3008185830) located in Akishima-shi T?ky?, JP. RegDataLab tracks 2 FDA inspections and 2 compliance actions at this facility.
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What FDA found at this site
- Latest inspection
- Apr 21, 2015: Official Action Indicated (OAI)
- Inspections on record
- 2 (1 OAI, 1 NAI)
- Last OAI inspection
- Apr 21, 2015
- Warning letters
- 2 listed by FDA for this FEI, latest Jan 1, 2023
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 21, 2015 | Official Action Indicated (OAI) | Design verification - output does not meet input requirement (21 CFR 820.30(f)) Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Lack of or inadequate procedures (21 CFR 820.100(a)) Design validation - user needs and intended uses (21 CFR 820.30(g)) and 2 more |
| Jul 15, 2014 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Hoya Corporation - Pentax Life Division
- Location
- Akishima-shi T?ky? (JP)
- Source
- device