21 CFR 820 / FDA Inspection

1. MANUFACTURER INFORMATION
Legal Manufacturer / OEM / OBL Name*
Street*
City /Pincode*
Country*
Website Address
2. ADMINISTRATIVE INFORMATION
Scope of CERT3GLOBAL	Select 21 CFR 820 GAP Assessment Guidance and Implementation Support FDA Pe-Audit Support FDA Post Audit Support and Closing of 483
Scope of Manufacturer	Select Design, Manufacturer and Sale of Device Manufacturer and Sale of Device Assembly, Packing, Labelling and Sale of Device Third-party Manufacturing and Sale of Device Own Brand Labeler(OBL)
Number of employees covered in the above scope	Select 1-10 <30 <100
Documentation and Device Knowledge of the person coordinate with Consultants	Select Good Average Poor
3. MEDICAL DEVICE DESCRIPTION
Type of Device	Select Standalone Software Active Device Non Active Device Procedural Pack (Kits) Reusable Surgical Instruments Medicinal Device Measuring Device Animal Origin Device
Name of the Medical device(s)
Medical Device Class	Select Class I Class II Class III Not Known
4. SUBMITTER INFORMATION
Contact Person* Select Mr Mrs Dr Prof Ms
Job Title*
Contact Number*
Contact Email*
Date