FDA Inspection
Maruho Plastic Solutions dba Relucent Plastic SolutionsMaruho Plastic Solutions dba Relucent Plastic Solutions – FDA Inspection, Mar 10, 2020
Record Details
This FDA Inspection record concerns Maruho Plastic Solutions dba Relucent Plastic Solutions, with an inspection on March 10, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 10, 2020
- Product Type
- Devices
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ID · 81a1212a-8353-4b4b-b5b3-bbaa2f0611d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1120346
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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