Attachment_27_FDA_Form_2684_Quarterly_Report.pdf

CONTRACT NUMBER

STATE CONTRACT MONTHLY FOOD REPORT

NAME DATE

INSTRUCTIONS

STATE AND AGENCY

REPORTING PERIOD

Follow detailed instructions on back of this page. Reports are due on the last working day of the following month. Negative reports are required.PREPARED

BY:

b. ROUTINE INSPECTIONS

c. REINSPECTIONS (Follow-ups to violative inspections)

d. VISITS (Out-of-Business, etc.)

a. TOTAL SAMPLES COLLECTED

b. NUMBER EXAMINED

c. NUMBER OF DETERMINATIONS

1. INSPECTIONS

ACCOMPLISHED

2. SAMPLES

(1) IN COMPLIANCE

d. CLASSIFICATION

(2) NOT IN COMPLIANCE

a. WARNING LETTERS

b. EMBARGOES/SEIZURES

c. HEARINGS CONDUCTED

d. PROSECUTIONS/INJUNCTIONS

e. OTHER ACTIONS (Specify type)

3. COMPLIANCE ACTIONS

4. HIGHLIGHTS AND

PROBLEMS

ENCOUNTERED.

On an attached sheet of paper, write a brief narrative detailing any major actions occurring, corrections achieved, problems with contract operations, work, etc.

FORM FDA 2684 (4/11) PREVIOUS EDITION IS OBSOLETE

a. TOTAL INSPECTIONS

PSC Graphics (301) 443-1090 EF

Other Actions - Actions not fitting above categories (i.e., recalls, license suspensions, administrative penalties) should be reported here and type of action(s) should be specified.

INSTRUCTIONS FOR COMPLETING FORM FDA 2684 (4/02)

1. Inspections Accomplished - Report total inspections for month, and a breakout by routine, etc., inspections. The sum of b + c + d must equal the total number of inspections reported.

"Visits" (line "d") are reported when an inspection cannot be completed because an establishment is found to be out-of-business, not Official Establishment Inventory (OEI), or inactive.

Samples - Breakout data for total number of samples reported in that month.2.

3. Compliance Actions - Taken as a result of contract inspections.

a. Warning Letters - Include all letters and notices sent to a firm's management informing or warning them of adverse conditions found during an inspection.

b. Embargoes/Seizures - Number of actions taken in conjunction with inspections, which withhold or remove merchandise from the market.

Hearings Conducted - Number held as a result of inspections.c.

d.

4.

Food and Drug Administration/ORA/ORO Division of Federal-State Relations 12420 Parklawn Drive, ELEM-3028 Rockville, MD 20857 and

Food and Drug Administration 5630 Fishers Lane Room 2128, HFA-500 (Name of Specialist) Rockville, MD 20857

Prosecutions/Injunctions - Include court actions, i.e., prosecutions, and injunctions. Report number when action filed. Include summary of results on continuation sheet upon completion of action, but do not count again.

Reporting - Include with this report a list of the establishments inspected, indicating firm name, city, date inspected and number of samples collected. Submit the original to FDA District Office with copies to:

FORM FDA 2684 (4/11) PREVIOUS EDITION IS OBSOLETE

FORM FDA-2684

PSC Graphics

HHS/FDA

State Contract Monthly Food Report

CONTRACT NUMBER

STATE CONTRACT MONTHLY FOOD REPORT

NAME

DATE

INSTRUCTIONS

STATE AND AGENCY

REPORTING PERIOD

Follow detailed instructions on back of this page. Reports are due on the last working day of the following month. Negative reports are required.

PREPARED BY:

b. ROUTINE INSPECTIONS

c. REINSPECTIONS (Follow-ups to violative inspections)

c. Reinspections (Follow ups to violative inspections).

d. VISITS (Out-of-Business, etc.)

d. Visits (Out of Business, etcetera).

a. TOTAL SAMPLES COLLECTED

b. NUMBER EXAMINED

c. NUMBER OF DETERMINATIONS

1. INSPECTIONS ACCOMPLISHED

2. SAMPLES

(1) IN COMPLIANCE

d. CLASSIFICATION

(2) NOT IN COMPLIANCE

a. WARNING LETTERS

b. EMBARGOES/SEIZURES

c. HEARINGS CONDUCTED

d. PROSECUTIONS/INJUNCTIONS

e. OTHER ACTIONS (Specify type)

3. COMPLIANCE ACTIONS

4. HIGHLIGHTS AND PROBLEMS ENCOUNTERED.

On an attached sheet of paper, write a brief narrative detailing any major actions occurring, corrections achieved, problems with contract operations, work, etc.

On an attached sheet of paper, write a brief narrative detailing any major actions occurring, corrections achieved, problems with contract operations, work, etcetera.

FORM FDA 2684 (4/11)

FORM FDA 26 84 (April 2011).

PREVIOUS EDITION IS OBSOLETE

a. TOTAL INSPECTIONS PSC Graphics (301) 443-1090 EF P S C Graphics (3 0 1) 4 4 3 - 1 0 9 0. E F.

Other Actions - Actions not fitting above categories (i.e., recalls, license suspensions, administrative penalties) should be reported here and type of action(s) should be specified.

Other Actions - Actions not fitting above categories (i. e., recalls, license suspensions, administrative penalties) should be reported here and type of action or actions should be specified.

INSTRUCTIONS FOR COMPLETING FORM FDA 2684 (4/02)

INSTRUCTIONS FOR COMPLETING FORM FDA 2684 (April 2002).

1.

Inspections Accomplished - Report total inspections for month, and a breakout by routine, etc., inspections. The sum of b + c + d must equal the total number of inspections reported."Visits" (line "d") are reported when an inspection cannot be completed because an establishment is found to be out-of-business, not Official Establishment Inventory (OEI), or inactive.

Inspections Accomplished - Report total inspections for month, and a breakout by routine, etcetera, inspections. The sum of b plus c plus d must equal the total number of inspections reported. "Visits" (line "d") are reported when an inspection cannot be completed because an establishment is found to be out of business, not Official Establishment Inventory (O E I), or inactive.

Samples - Breakout data for total number of samples reported in that month.

2.

3.

Compliance Actions - Taken as a result of contract inspections.

a.

Warning Letters - Include all letters and notices sent to a firm's management informing or warning them of adverse conditions found during an inspection.

b.

Embargoes/Seizures - Number of actions taken in conjunction with inspections, which withhold or remove merchandise from the market.

Hearings Conducted - Number held as a result of inspections.

c.

d.

4.

Food and Drug Administration/ORA/ORO Division of Federal-State Relations12420 Parklawn Drive, ELEM-3028 Rockville, MD 20857 Food and Drug Administration/O R A/O R O Division of Federal State Relations 1 2 4 2 0 Parklawn Drive, E L E M - 30 28 Rockville, Maryland 2 0 8 5 7.

and Food and Drug Administration 5630 Fishers LaneRoom 2128, HFA-500 (Name of Specialist)Rockville, MD 20857 Food and Drug Administration 56 30 Fishers Lane Room 21 28, H F A - 500 (Name of Specialist) Rockville, Maryland 2 0 8 5 7.

Prosecutions/Injunctions - Include court actions, i.e., prosecutions, and injunctions. Report number when action filed. Include summary of results on continuation sheet upon completion of action, but do not count again.

Prosecutions/Injunctions - Include court actions, i. e., prosecutions, and injunctions. Report number when action filed. Include summary of results on continuation sheet upon completion of action, but do not count again.

Reporting - Include with this report a list of the establishments inspected, indicating firm name,city, date inspected and number of samples collected. Submit the original to FDA District Office with copies to:

FORM FDA 2684 (4/11)

FORM FDA 26 84 (April 2011).

PREVIOUS EDITION IS OBSOLETE