Form Fda 2966 PDF Details

The Food and Drug Administration (FDA) has released Form FDA 2966, the Registration of Clinical Investigators for Drugs and Biological Products. This form is for clinical investigators who are conducting clinical investigations of new drugs, biologics, or medical devices regulated by the FDA. The form must be submitted by each investigator before beginning any clinical studies. In addition to registering as a clinical investigator, investigators must also meet certain requirements in order to conduct studies with FDA-regulated products. These requirements vary depending on the type of study being conducted and the product being studied. By familiarizing themselves with these requirements, investigators can ensure that they are conducting their studies in compliance with FDA regulations.

QuestionAnswer
Form NameForm Fda 2966
Form Length4 pages
Fillable?No
Fillable fields0
Avg. time to fill out1 min
Other namesform gmp, form gmp pdf, form food inspection report, form food inspection

Form Preview Example

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

FOOD GMP INSPECTION REPORT

1. Establishment Name and Address (Include ZIP code)

2.Date Inspected

3.Product(s) Inspected

4. FEI#

5. State License or Permit Number

6. Name and Title of Responsible Plant Official

7.Telephone Number (Include Area Code)

8. Name and Title of Responsible Corporate Official

9.Telephone Number (Include Area Code)

INSTRUCTIONS:

Answer the following questions by checking the appropriate box. Explain “No”, answers on continuation sheet(s).

Precede each explanation with the item number. Use “N/A” where questions are Not Applicable.

INSPECTION CRITERIA

No.

Plants and Grounds

Yes

No

N/A

 

 

 

 

 

1.

Are premises free of harborages and/or breeding places for rodents, insects and other pests?

 

 

 

 

 

 

 

 

2.

Is adequate drainage provided to avoid contamination of facilities and products?

 

 

 

 

 

 

 

 

3.

Is sufficient space provided for placement of equipment, storage of materials and for production

 

 

 

operations?

 

 

 

 

 

 

 

 

 

 

 

 

4.

Are floors, walls and ceilings constructed of easily cleanable materials and kept clean and in good repair?

 

 

 

 

 

 

 

 

5.

Are food and food contact surfaces protected from contamination from pipes, etc., over working areas?

 

 

 

 

 

 

 

 

6.

Are food processing areas effectively separated from other operations which may cause contamination

 

 

 

of food being processed?

 

 

 

 

 

 

 

 

 

 

 

 

7.

Are food products and processing areas protected against contamination from breakage of light bulbs

 

 

 

and other glass fixtures?

 

 

 

 

 

 

 

 

 

 

 

 

8.

Is air quality and ventilation adequate to prevent contamination by dust and/or other airborne substances?

 

 

 

9.Are doors, windows and other openings protected to eliminate entry by insects, rodents and other pests?

Equipment and Utensils

10.Are all utensils and equipment constructed of adequately cleanable materials and suitable for their intended uses?

11.Is the equipment designed and used in a manner that precludes contamination with lubricants, contaminated water, metal fragments, etc.?

12.Is the equipment installed and maintained so as to facilitate the cleaning of equipment and adjacent areas?

FORM FDA 2966 (3/13)

Page 1 of 4

PSC Publishing Services (301) 443-6740 EF

INSPECTION CRITERIA

No.

Sanitary Facilities and Controls

Yes No N/A

13.Is the water supply adequate in quantity and quality for its intended uses?

14.Are the water temperatures and pressures maintained at suitable levels for its intended use?

15.Is the sewage disposal system adequate?

16.

Is the plumbing adequately sized, designed, installed and maintained in a manner to prevent

contamination?

 

17.Are adequate toilet rooms provided, equipped and maintained clean and in good repair?

18.Are adequate handwashing and/or sanitizing facilities provided where appropriate?

19.

Is all refuse properly stored and protected where necessary from insects, rodents and other pests

and disposed of in an adequate manner?

 

 

 

 

Sanitary Operations

20.Is the facility kept clean and in good physical repair?

21.

Is cleaning of facilities and equipment conducted in such a manner as to avoid contamination

of food products?

 

22.Are detergents, sanitizers, hazardous materials and other supplies used in a safe and effective manner?

23.

Are cleaning compounds and hazardous materials kept in original containers, stored separate

from raw materials?

 

24.Are the processing areas maintained free of insects, rodents and other pests?

25.Are insecticides and rodenticides used and stored so as to prevent contamination of food?

 

26.

Are all utensils and equipment cleaned and sanitized at intervals frequently enough to avoid

 

 

contamination of food products?

 

 

 

 

 

 

 

 

 

27.

Are single service articles stored, handled, dispensed, used and disposed of in a manner that

 

 

prevents contamination?

 

 

 

 

 

 

 

 

 

28.

Are utensils and portable equipment stored so as to protect them from splash, dust and other

 

 

contamination?

 

 

 

 

 

 

 

 

 

 

Processes and Controls

 

 

29.

Is responsibility for overall plant sanitation specifically assigned to an individual?

 

 

 

 

 

 

 

 

 

 

 

 

30.

Are raw materials and ingredients adequately inspected, processed as necessary and stored

 

 

 

 

 

to assure that only clean, wholesome materials are used?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

31.

Is ice (where used) manufactured from potable water and stored and handled in a sanitary manner?

 

 

 

 

 

 

 

 

 

 

 

 

32.

Is food processing conducted in a manner to prevent contamination and minimize harmful

 

 

 

 

 

microbiological growth?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

33.

Are chemical, microbiological, or extraneous material testing procedures used where necessary

 

 

 

 

 

to identify sanitation failures of food contamination?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

34.

Are packaging processes and materials adequate to prevent contamination?

 

 

 

 

 

 

 

 

 

 

 

 

35.

Are only approved food and/or color additives used?

 

 

 

 

 

 

 

 

 

 

 

FORM FDA 2966 (3/13)

Page 2 of 4

INSPECTION CRITERIA

No.

Processes and Controls

Yes

No

N/A

 

 

 

 

 

36.

Are products coded to enable positive lot identification, and are records maintained

 

 

 

in excess of expected shelf-life?

 

 

 

 

 

 

 

37.Are weighing and measuring practices adequate to ensure the declared quantity of contents?

38.Are labels of products covered during inspection in compliance? (submit violative labels as exhibits)

39.

Are finished products stored and shipped under conditions which will avoid contamination

and deterioration?

 

 

 

 

DETAILS OF MANUFACTURING PROCEDURES AND CONTROLS

Provide brief description of manufacturing processes and controls for product(s) inspected. Where appropriate, report times, temperatures, and other critical processing steps. If microbiological or any other type of contamination is suspected or encountered, fully describe the relationship between the routes of contamination and the process. Use flow charts where appropriate. If more space is needed, use continuation sheet.

No.

 

Personnel

Yes

No

N/A

 

 

 

 

 

 

40.

Are personnel with illness, sores, infections, etc., restricted from handling food products?

 

 

 

 

 

 

 

 

41.

Do employees wear clean outer garments, use adequate hair restraints and remove excess

 

 

 

jewelry when handling food?

 

 

 

 

 

 

 

 

 

 

 

 

42.

Do employees thoroughly wash and sanitize hands as necessary?

 

 

 

 

 

 

 

 

43.

Do employees refrain from eating, drinking and smoking and observe good food handling techniques

 

 

 

in processing areas?

 

 

 

 

 

 

 

 

 

 

 

 

 

FORM FDA 2966 (3/13)

Page 3 of 4

CORRECTIONS AND SAMPLES

If any corrections were made as a result of this inspection or made as a result of a previous inspection (including voluntary destructions, capital improvements, etc.), complete Voluntary Correction section of cover sheet Form FDA 481 (E) CG.

If any samples were collected, list sample numbers and briefly describe samples.

DISCUSSIONS WITH MANAGEMENT

Indicate individual with whom inspection was discussed. Identify official (name and title) having authority to authorize corrections. Record any recommendations/warnings given, and management’s response.

CONTINUATION SHEET

(Use additional sheets as appropriate.)

Signature of Inspector

Date

FORM FDA 2966 (3/13)

Page 4 of 4

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Simple tips to prepare how to form gmp stage 1

2. Right after the previous part is done, go on to enter the relevant information in these - Plants and Grounds, Yes, Are premises free of harborages, Is adequate drainage provided to, Is sufficient space provided for, Are floors walls and ceilings, Are food and food contact surfaces, Are food processing areas, Are food products and processing, Is air quality and ventilation, Are doors windows and other, Equipment and Utensils, Are all utensils and equipment, Is the equipment designed and used, and Is the equipment installed and.

Completing segment 2 of how to form gmp

3. The following section will be about Sanitary Facilities and Controls, Yes, Is the water supply adequate in, Are the water temperatures and, Is the sewage disposal system, Is the plumbing adequately sized, Are adequate toilet rooms provided, Are adequate handwashing andor, Is all refuse properly stored and, Is the facility kept clean and in, Sanitary Operations, Is cleaning of facilities and, Are detergents sanitizers, and Are cleaning compounds and - fill in all of these empty form fields.

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4. Your next part will require your input in the subsequent parts: Are the processing areas, Are insecticides and rodenticides, Are all utensils and equipment, Are single service articles stored, Are utensils and portable, Processes and Controls, Is responsibility for overall, Are raw materials and ingredients, Is ice where used manufactured, Is food processing conducted in a, and Are chemical microbiological or. It is important to type in all requested information to move forward.

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Always be really attentive while filling in Are raw materials and ingredients and Processes and Controls, because this is where many people make errors.

5. The very last point to complete this form is essential. You must fill in the required blank fields, particularly Are packaging processes and, Are only approved food andor color, FORM FDA, and Page of, prior to submitting. Neglecting to do this may give you an unfinished and possibly unacceptable form!

how to form gmp completion process clarified (part 5)

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