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

:
:

:
:
:
: