Form Fda 3610 – Fill Out and Use This PDF

Form FDA 3610 is a document that's crucial to the proper start and functioning of new drugs. This form is mandatory when submitting an application for authorization to market a new drug. It ensures that essential information relating to the product and its labeling is complete, accurate, and updated. It also guarantees that safety studies are conducted as required by laws and regulations. Submitting this paperwork helps pharmaceutical companies expedite their pursuit of getting new medicine into circulation effectively as possible. Submitting Form FDA 3610 can immensely advance the success of an upcoming medication in its journey to seeing the light of day for consumption!

Form Fda 3610 PDF Details

The FDA (Food and Drug Administration) has created a new form, Form 3610, for drug sponsors to use when submitting information about a drug’s safety. The purpose of this new form is to ensure that all safety information associated with the drug is captured in one place. This will help to improve communication between the sponsor and the FDA, as well as between the sponsor and other stakeholders. By using Form 3610, sponsors can provide a more complete picture of the safety profile of their drug product.

Question	Answer
Form Name	Form Fda 3610
Form Length	7 pages
Fillable?	No
Fillable fields	0
Avg. time to fill out	1 min 45 sec
Other names	fda form 3610, MISBRANDED, haccp, PREINSPECTION

Form Preview Example

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CONTRACT AUDIT

FDA AUDITOR

FIRM

FIRM ADDRESS

STATE INSPECTOR

CFN / FEI NUMBER

PRODUCT(S) COVERED

DATE

TIME IN

TIME OUT

OVERALL RATING

Acceptable

Needs Improvement

I.	PREINSPECTION ASSESSMENT

1.DID THE INSPECTOR REVIEW THE STATE’S ESTABLISHMENT FILE FOR THE PREVIOUS INSPECTION REPORT AND POSSIBLE COMPLAINTS OR ACCESS OTHER AVAILABLE RESOURCES IN PREPARATION FOR THE INSPECTION?

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

2.DID THE INSPECTOR HAVE THE APPROPRIATE EQUIPMENT AND FORMS TO PROPERLY CONDUCT THE INSPECTION?

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

II.	INSPECTION OBSERVATIONS AND PERFORMANCE

1.WAS FDA JURISDICTION ESTABLISHED?

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

FORM FDA 3610 (10/03)

PAGE 1 OF 7

PSC Publishing Services (301) 443-6740 EF

II.		INSPECTION OBSERVATIONS AND PERFORMANCE (CONTINUED)

2.	DID THE INSPECTOR SELECT AN APPROPRIATE PRODUCT FOR THE INSPECTION AND, IF NECESSARY, MAKE APPROPRIATE ADJUSTMENTS BASED ON WHAT
	THE FIRM WAS PRODUCING?
	Acceptable	Needs Improvement
	COMMENTS (required for Needs Improvement)




3.	DID THE INSPECTOR ASSESS THE EMPLOYEE PRACTICES CRITICAL TO THE SAFE PRODUCTION AND STORAGE OF FOOD?
	Acceptable	Needs Improvement
	COMMENTS (required for Needs Improvement)




4.	DID THE INSPECTOR PROPERLY EVALUATE THE LIKELIHOOD THAT CONDITIONS, PRACTICES, COMPONENTS AND/OR LABELING COULD CAUSE THE
	PRODUCT TO BE ADULTERATED OR MISBRANDED?
	Acceptable	Needs Improvement
	COMMENTS (required for Needs Improvement)




5.	DID THE INSPECTOR RECOGNIZE SIGNIFICANT VIOLATIVE CONDITIONS OR PRACTICES IF PRESENT AND RECORD FINDINGS CONSISTENT WITH STATE
	PROCEDURES?
	Acceptable	Needs Improvement

COMMENTS (required for Needs Improvement)

FORM FDA 3610 (10/03)

PAGE 2 OF 7

II.		INSPECTION OBSERVATIONS AND PERFORMANCE (CONTINUED)

6.	DID THE INSPECTOR DEMONSTRATE THE ABILITY TO DISTINGUISH BETWEEN SIGNIFICANT VERSUS INSIGNIFICANT OBSERVATIONS AND ISOLATED
	INCIDENTS VERSUS TRENDS?
	Acceptable	Needs Improvement
	COMMENTS (required for Needs Improvement)




7.	DID THE INSPECTOR REVIEW AND EVALUATE THE APPROPRIATE RECORDS AND PROCEDURES FOR THIS ESTABLISHMENT’S OPERATION AND EFFECTIVELY
	APPLY THE INFORMATION OBTAINED FROM THIS REVIEW?
	Acceptable	Needs Improvement
	COMMENTS (required for Needs Improvement)




8.	DID THE INSPECTOR COLLECT ADEQUATE EVIDENCE AND DOCUMENTATION IN ACCORDANCE WITH STATE PROCEDURES GIVEN THE NATURE OF THE
	INSPECTIONAL FINDINGS?
	Acceptable	Needs Improvement
	COMMENTS (required for Needs Improvement)




9.	DID THE INSPECTOR VERIFY CORRECTION OF DEFICIENCIES IDENTIFIED DURING THE PREVIOUS STATE INSPECTION?
	Acceptable	Needs Improvement

COMMENTS (required for Needs Improvement)

FORM FDA 3610 (10/03)

PAGE 3 OF 7

II.		INSPECTION OBSERVATIONS AND PERFORMANCE (CONTINUED)
II.		INSPECTION OBSERVATIONS AND PERFORMANCE (CONTINUED)

10. DID THE INSPECTOR ACT IN A PROFESSIONAL MANNER AND DEMONSTRATE PROPER SANITARY PRACTICES DURING THE INSPECTION?
	Acceptable	Needs Improvement
	COMMENTS (required for Needs Improvement)




II.A.		INSPECTION OBSERVATIONS AND PERFORMANCE FOR "HACCP-REGULATED" FACILITIES
II.A.

Note to Auditor: These four questions apply to only firms subject to HACCP regulations. These four questions should be left

		blank for firms not subject to HACCP regulations.


1.	DID THE INSPECTOR USE THE "FISH AND FISHER PRODUCTS HAZARDS AND CONTROLS GUIDE" OR THE "JUICE HACCP HAZARDS AND CONTROLS GUIDE," AS
	APPROPRIATE, TO IDENTIFY AND EVALUATE THE HAZARDS ASSOCIATED WITH THE PRODUCT AND PROCESS?
	Acceptable	Needs Improvement
	COMMENTS (required for Needs Improvement)




2.	DID THE INSPECTOR ASSESS THE FIRM’S IMPLEMENTATION OF SANITATION MONITORING FOR THE APPLICABLE EIGHT KEY AREAS OF SANITATION?
	Acceptable	Needs Improvement
	COMMENTS (required for Needs Improvement)




3.	DID THE INSPECTOR REVIEW THE FIRM’S HACCP PLAN (OR NECESSARY PROCESS CONTROLS IN THE ABSENCE OF A HACCP PLAN) AND APPLICABLE
	MONITORING, VERIFICATION AND CORRECTIVE ACTION RECORDS, INCLUDING THOSE RELATED TO SANITATION?
	Acceptable	Needs Improvement

COMMENTS (required for Needs Improvement)

FORM FDA 3610 (10/03)

PAGE 4 OF 7

II.A. INSPECTION OBSERVATIONS AND PERFORMANCE FOR "HACCP-REGULATED" FACILITIES (CONTINUED)

4.DID THE INSPECTOR RECOGNIZE DEFICIENCIES IN THE FIRM’S MONITORING AND SANITATION PROCEDURES THROUGH IN-PLANT OBSERVATIONS?

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

III.	ORAL AND WRITTEN COMMUNICATION

1.DID THE INSPECTOR IDENTIFY HIMSELF/HERSELF AND MAKE APPROPRIATE INTRODUCTIONS, WHICH INCLUDE EXPLAINING THE PURPOSE AND SCOPE OF THE INSPECTION?

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

2.DID THE INSPECTOR USE SUITABLE INTERVIEWING TECHNIQUES?

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

3.DID THE INSPECTOR EXPLAIN FINDINGS CLEARLY AND ADEQUATELY THROUGHOUT THE INSPECTION?

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

FORM FDA 3610 (10/03)

PAGE 5 OF 7

III.	ORAL AND WRITTEN COMMUNICATION (CONTINUED)

4.DID THE INSPECTOR ALERT THE FIRM’S APPROPRIATE MANAGEMENT WHEN AN IMMEDIATE CORRECTIVE ACTION WAS NECESSARY?

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

5.DID THE INSPECTOR ANSWER QUESTIONS AND PROVIDE INFORMATION IN AN APPROPRIATE MANNER?

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

6.DID THE INSPECTOR WRITE THEIR FINDINGS ACCURATELY, CLEARLY AND CONCISELY ON THE STATE FORM/DOCUMENT LEFT WITH THE FIRM?

Acceptable

Needs Improvement

COMMENTS (required for Needs Improvement)

NOTE: EVERY ITEM MARKED "NEEDS IMPROVEMENT" MUST BE ACCOMPANIED BY AN EXPLANATION OF WHY THE ITEM WAS JUDGED AS NEEDING IMPROVEMENT.

Overall Rating:

If three or less items are marked "needs improvement," the overall rating is "acceptable." If four or more items are marked "needs improvement," the overall rating is "needs improvement." The overall rating must be marked in the space provided in the header on the first page.

All questions must be answered "acceptable" or "needs improvement," except for section II.A. Inspection Observations and Performance for "HACCP-Regulated" Facilities. If the establishment is not subject to Seafood or Juice HACCP regulations, leave the scoring for these four questions blank.

If four or more evaluated items are marked as "needs improvement," the state program manager must be notified by the appropriate FDA liaison that additional training or other performance improvement measures for the inspector being audited should be initiated. All contract inspectors who receive an overall audit score of "needs improvement" shall receive remedial training in deficient areas or as agreed upon by the FDA Project and Co-Project Officers prior to resuming contract inspection duties.

FORM FDA 3610 (10/03)

PAGE 6 OF 7

ADDITIONAL COMMENTS

SIGNATURE OF FDA AUDITOR

FORM FDA 3610 (10/03)

PAGE 7 OF 7

DATE

How to Edit Form Fda 3610 Online for Free

You can fill out III easily with the help of our online PDF editor. The tool is constantly maintained by us, receiving cool features and turning out to be better. Starting is simple! All you have to do is follow these simple steps down below:

Step 1: Click on the "Get Form" button above. It will open up our pdf editor so you could start filling out your form.

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It will be easy to complete the document with our practical guide! Here's what you must do:

1. It is advisable to complete the III properly, thus be mindful while working with the sections comprising these blank fields:

INSPECTIONAL writing process described (step 1)

2. The subsequent part would be to fill out the next few fields: DID THE INSPECTOR HAVE THE, Acceptable, Needs Improvement, COMMENTS required for Needs, INSPECTION OBSERVATIONS AND, WAS FDA JURISDICTION ESTABLISHED, Acceptable, Needs Improvement, and COMMENTS required for Needs.

Simple tips to fill out INSPECTIONAL part 2

3. In this particular step, examine DID THE INSPECTOR SELECT AN, THE FIRM WAS PRODUCING, Acceptable, Needs Improvement, COMMENTS required for Needs, DID THE INSPECTOR ASSESS THE, Acceptable, Needs Improvement, and COMMENTS required for Needs. These will have to be completed with greatest accuracy.

It is possible to make errors while filling in your Needs Improvement, so be sure to go through it again before you decide to send it in.

4. This specific part arrives with the following fields to fill out: DID THE INSPECTOR PROPERLY, PRODUCT TO BE ADULTERATED OR, Acceptable, Needs Improvement, COMMENTS required for Needs, DID THE INSPECTOR RECOGNIZE, PROCEDURES, Acceptable, Needs Improvement, and COMMENTS required for Needs.

INSPECTIONAL conclusion process explained (part 4)

5. While you draw near to the finalization of your form, you'll notice several extra points to undertake. Mainly, INCIDENTS VERSUS TRENDS, Acceptable, Needs Improvement, COMMENTS required for Needs, DID THE INSPECTOR REVIEW AND, APPLY THE INFORMATION OBTAINED, Acceptable, Needs Improvement, and COMMENTS required for Needs should all be filled in.

Step 3: Make sure your information is correct and simply click "Done" to proceed further. Try a free trial account with us and acquire immediate access to III - readily available in your personal account page. We do not share or sell any information you type in while completing forms at FormsPal.

Form Fda 3610 – Fill Out and Use This PDF

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