1068521

Acuity Polymers, Inc. — FEI 3012228452

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 9, 2018
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Rochester, NY (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310221 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
328621 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
63021 CFR 803.17Lack of Written MDR Procedures