Fda 2541A Form PDF Details

In the realm of food safety and regulatory compliance, the Form FDA 2541a plays a crucial role for commercial processors of acidified and low-acid canned foods. Issued by the Department of Health and Human Services’ Food and Drug Administration, this form is essential for the establishment registration and process filing requirements detailed under 21 CFR 108.25(c)(1) and (2) for acidified foods and 21 CFR 108.35(c)(1) and (2) for low-acid canned foods. Structured to capture comprehensive information about the product, processing method, container type, and critical factors to ensure commercial sterility, the form acts as a vital checkpoint in safeguarding public health against the risks of improperly processed foods. The detailed sections within the form guide the processors in declaring the name, form, or style of the product, packing medium, pH, and other specific attributes like the method of acidification or preservatives used. It emphasizes the role of the processor in identifying and controlling critical factors, such as the arrangements of pieces in the container, maximum water activity, and consistency that assures the safety of the food product once it hits the market. With an expiration date clearly marked, and a note emphasizing that no commercial processor shall engage in the processing of these food categories without submitting the completed Forms FDA 2541 and FDA 2541a, the significance of this document in the regulatory landscape cannot be overstated. The form not only facilitates compliance but also aligns with the broader goals of the FDA in promoting food safety and protecting consumers from foodborne illnesses.

QuestionAnswer
Form NameFda 2541A Form
Form Length3 pages
Fillable?No
Fillable fields0
Avg. time to fill out45 sec
Other namestumble form fda blank, process methods acid aseptic, fda food process except, tumble form fda

Form Preview Example

 

 

 

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

 

FOOD AND DRUG ADMINISTRATION

(Use FDA booklet titled: "Instructions for Establishment Registration and

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Process Filing for Acidified and Low-Acid Canned Foods" for completing

FORM APPROVED: OMB NO. 0910-0037

 

 

 

 

 

 

 

FOOD PROCESS FILING FOR ALL METHODS EXCEPT LOW-ACID ASEPTIC

Form FDA 2541a.)

EXPIRATION DATE: 2/28/2015

A. PRODUCT

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See PRA Statement on page 3.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Name, Form or Style, and Packing Medium:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

pH:

 

 

 

 

.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2 0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Before Acidification)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Governing Regulation:

Type of Submission:

 

Process Use:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Y Y Y Y M M D D S S S

 

 

 

 

 

 

FCE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SID

 

low-acid (21 CFR 108.35/113)

new

 

 

 

scheduled

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

acidified (21 CFR 108.25/114)

replaces

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

alternate for

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

cancels

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

emergency for

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PROCESSING METHOD

NAME OF STERILIZER (MFR. & TYPE)

HEATING MEDIUM (e.g., Steam, water, immersion or spray, steam-air)

1.

Still

 

 

2.

 

Agitating

3.

Hydrostatic

 

4.

Flame

5.

Other (explain)

 

6.

 

Acidified

 

 

.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a.

Horizontal

b.

Vertical

 

a.

End over End

 

 

Inner Chain only

 

 

 

 

 

 

 

 

 

 

Maximum Equilibrium pH:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Divider Plates (complete for a. or b.)

 

 

Axial

 

 

Outer Chain only

 

 

 

 

 

 

 

 

 

 

Method of Acidification:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

None

Perforated

 

 

 

 

 

Both Inner and

 

 

 

 

 

 

 

 

 

 

Acidifying Agent:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

b.

Continuous

 

 

Outer Chain

 

 

 

 

 

 

 

 

 

 

Pasteurization Method:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

c.

Crateless

 

 

 

 

Batch

 

 

Single Chain

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Bottom Surface (complete for c.)

 

 

 

 

 

Multiple Chain

 

 

 

 

 

 

 

 

 

 

Preservative Used:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Solid

 

Perforated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

. , . , .

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Concentration:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CONTAINER TYPE:

 

 

 

 

 

 

3.

Glass or Ceramic

 

 

 

 

 

5.

 

 

Semirigid (specify material):

Lid

 

 

 

 

 

 

 

 

Body

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1.

Tinplate/Steel Can

2-piece

 

Welded

 

4.

Flexible Pouch

(specify material):

 

 

 

 

 

Seal Method

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Aluminum Can

 

3-piece

 

Cemented

 

 

 

 

 

 

 

 

 

6.

 

 

Other (specify):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROCESS ESTABLISHMENT SOURCE (Limit entry to 30 characters)

 

 

 

 

 

DATE LAST ESTABLISHED

 

 

PROCESS RECOMMENDATIONS ATTACHED?

YES

Y Y Y Y M M

NO

C.CRITICAL FACTORS: AS DELINEATED BY PROCESS AUTHORITY TO ASSURE COMMERCIAL STERILITY (Check or Describe)

None of the following

NO

(.

 

 

 

 

 

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Arrangements of Pieces in Container

AP

 

 

 

 

 

 

 

 

 

 

 

 

 

Maximum Water Activity (a

w)

MW

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Formulation Changes

FC

 

 

 

 

 

 

 

 

 

 

 

 

 

Consistency / Viscosity

CV

(

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

)

Preparation Method

PM

 

 

 

 

 

 

 

 

 

 

 

 

 

Value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product Quality

PQ

 

 

 

 

 

 

 

 

 

 

 

 

 

Units

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Matting Tendency

MT

 

 

 

 

 

 

 

 

 

 

 

 

 

Method Name

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.)

 

 

 

 

 

 

 

 

 

Layer Pack

LP

 

 

 

.

 

 

 

 

 

 

 

 

Temperature

 

(

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(

 

 

 

 

 

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Max. Flexible Pouch/Semirigid Container Thickness in Retort

MP

 

 

.

 

 

Container Position in Retort

CP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Max. Residual Air (Flexible Pouch/Semigrid Container)

MR

(

 

 

 

 

 

 

 

) c.c.

Nesting of Containers

NC

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Particle Size

PS

(

 

 

 

 

.

 

 

)

 

Fill Method (check applicable method)

FM

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Syrup Strength

SS

 

 

 

 

 

 

Hand or Volumetric

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Starch Added

SA

(

 

 

 

 

.

 

)

 

Vibrating or Tumble

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Max. %

 

 

 

 

 

 

 

Other (specify)

 

 

 

 

 

 

 

 

 

 

 

.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Type

 

 

 

 

 

 

 

 

 

 

 

 

 

 

% Solids

SO

(

 

 

 

 

 

 

 

 

 

 

 

)

 

 

 

 

 

 

 

 

 

Other Binder

OB

 

 

 

 

 

 

 

.

 

 

 

 

 

Solid to Liquid Ratio (wt. to wt.)

SL

(

 

 

 

.

 

 

.

 

 

 

)

 

 

 

 

 

 

 

 

 

Min. % Moisture of Dry Ingredients

MM

(

 

 

 

 

 

 

 

)

 

Drained wt./Net wt. Ratio

DW

(

 

 

 

 

 

 

 

 

 

 

)

 

 

 

 

 

 

 

 

 

 

Other (specify)

OT

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FORM FDA 2541a (4/12)

Page 1

PREVIOUS EDITION IS OBSOLETE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NOTE: No commercial processor shall engage in the processing of low-acid or acidified foods unless completed Forms FDA 2541 and

 

 

 

PSC Publishing Services (301) 443-6740 EF

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA 2541a have been filed with the Food and Drug Administration, 21 CFR 108.25(c)(1) and (2) and 108.35(c)(1) and (2).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

D. SCHEDULED PROCESS

(Do NOT write in shaded areas -- Check appropriate box and enter numerical values on dashed

FCE:

SID:

lines.)

 

 

 

 

 

 

 

 

 

 

 

CONTAINER

CAPACITY

SCHEDULED PROCESS

OTHER CRITICAL FACTORS TO ASSURE

 

OTHER

DIMENSIONS

UNITS

(Check Only One in Each Column)

COMMERCIAL STERILITY PER SOURCE AUTHORITY

 

(Specify)

Cont. Diameter or

Height or

Height or

 

Step Temperature Process Time

Sterilization

Least Sterilizing

 

 

 

 

 

 

Maximum

Minimum

Minimum

Minimum

Maximum

 

Thruput

Headspace

 

Speed

 

Free Liq. at

Container

No.

Length

Width

 

No.

 

Temperature

Value of the

 

 

Weight

Net Weight

Pouch or

 

 

 

 

 

 

 

 

 

Closing

Closing

 

 

 

 

 

 

 

Scheduled Process

 

 

 

 

 

 

 

 

 

 

 

Semirigid

 

 

LACF

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reel

Steps

Chain /

 

 

 

Machine

 

 

 

Container

 

 

Process

Process

 

 

 

 

 

 

 

Gauge

 

 

 

Oz.

Min.IT

F0

 

 

Reel Speed

Per Turn

Conveyer

 

 

 

 

 

 

Thickness

Time

Temp.

 

 

Diameter

 

 

 

 

 

 

 

 

 

 

 

Vacuum

 

 

 

 

Gal.

 

 

 

Other F Value

 

 

 

 

of Reel

Speed

 

 

 

 

 

 

 

Acidified or a w Controlled

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ML

 

 

 

 

 

 

Feet

 

 

 

 

 

 

 

 

 

 

 

Death Rate (z):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Process

Process

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

Min.IT

 

 

 

 

 

 

Carriers

 

 

 

Temp.

 

 

 

 

Time

Temp.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(± 3° F)

 

 

 

 

 

 

 

 

 

 

Net

 

 

 

Flights

Drained

 

 

 

 

 

 

 

 

 

 

Ref. Temp.(T):

 

 

 

 

 

 

 

 

 

 

 

 

 

Hold

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fill

 

 

 

Gross

 

 

 

(per minute)

Fill

 

 

 

 

 

 

 

 

Time

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Center

Other

 

IS Value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

N/A

N/A

N/A

Other:

N/A

N/A

 

N/A

 

N/A

N/A

N/A

N/A

 

Inches &

Inches &

Inches &

 

°F

Minutes

°F

 

Containers

Inches

RPM

Inches Number

Inches

Ounces

Ounces

Ounces

In. Hg.

 

Sixteenths Sixteenths Sixteenths

 

 

 

 

 

per Minute

 

 

 

 

 

 

 

 

 

.

 

 

 

.

 

 

 

.

 

.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 

 

.

.

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COMMENTS:

FOR FDA USE ONLY

PLANT NAME / ADDRESS

AUTHORIZED

FULL NAME

(Please Type or Print)

TELEPHONE NUMBER

 

INDIVIDUAL

 

 

 

PREFERRED

 

SIGNATURE

 

DATE

MAILING

 

 

 

 

ADDRESS

 

 

 

 

FORM FDA 2541a (4/12)

Page 2

 

 

 

LACF Contact Information

E-mail: LACF@FDA.HHS.GOV

Telephone: 240-402-2411

LACF REGISTRATION COORDINATOR (HFS-303) Center for Food Safety and Applied Nutrition Food and Drug Administration

5100 Paint Branch Parkway College Park, MD 20740

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information unless it displays a currently valid OMB number.”

FORM FDA 2541a (4/12) Page 3 PREVIOUS EDITION IS OBSOLETE

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