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Assessment Slip
FDA assessment slip for Foreign GMP Clearance
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ACCOUNTING SECTION’S COPY
Food and Drug Administration
AS S E SSM E NT SLIP
Foreign GMP Clearance
AS S E SSM E NT SLIP
Foreign GMP Clearance
PAIR COPY
DATE:
DTN:
Applicant Company
Address/Tel no.
LTO No.
:
:
:
Validity :
FOREIGN MANUFACTURER INFORMATION
Name of Manufacturer
Manufacturing Site
Address
DTN:
Applicant Company
Address/Tel no.
LTO No.
:
:
:
Validity :
FOREIGN MANUFACTURER INFORMATION
:
Manufacturing Lines
DATE:
:
:
Name of Manufacturer
Manufacturing Site
Address
:
Manufacturing Lines
:
APPLICATION DETAILS
Application Type
Foreign GMP Evidence Evaluation
Foreign GMP Inspection
(if disapproved from desktop evaluation)
Compliance
Renewal of GMP Clearance
Reissuance
Document Attachments (for self-assessment)
Letter of Request
GMP Evidence
Annex B
Annex C
Annex E
Letter of Request
Notice of Inspection
Annex C
Annex D
Copy of Notice of
Letter of Request
Deficiencies
Compliance Documents
Letter of Request
GMP Evidence
Annex B
Annex C
Copy of GMP
Annex E
Clearance
Copy of GMP
Letter of Request
Clearance
:
APPLICATION DETAILS
Application Type
Foreign GMP Evidence Evaluation
Foreign GMP Inspection
(if disapproved from desktop evaluation)
Compliance
Renewal of GMP Clearance
Reissuance
Others, please specify:
Others, please specify:
PAYMENT DETAILS
Document Attachments (for self-assessment)
Letter of Request
GMP Evidence
Annex B
Annex C
Annex E
Letter of Request
Notice of Inspection
Annex C
Annex D
Copy of Notice of
Letter of Request
Deficiencies
Compliance Documents
Letter of Request
GMP Evidence
Annex B
Annex C
Copy of GMP
Annex E
Clearance
Copy of GMP
Letter of Request
Clearance
PAYMENT DETAILS
APPLICANT
Fee
Surcharge
TOTAL
Evaluated by
CASHIER
Amount
OR Number
Date Issued
Received by
:
:
:
:
RECEIPT DETAILS
Name and Signature
Date
KJF
APPLICANT
Fee
Surcharge
TOTAL
Evaluated by
:
:
:
:
CASHIER
Amount
OR Number
Date Issued
Received by
:
:
:
:
RECEIPT DETAILS
:
:
Name and Signature
Date
KJF
:
:
:
:
:
:
