[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR114.100]

[Page 288]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 114_ACIDIFIED FOODS--Table of Contents
 
                      Subpart F_Records and Reports
 
Sec.  114.100  Records.


    (a) Records shall be maintained of examinations of raw materials, 
packaging materials, and finished products, and of suppliers' guarantees 
or certifications that verify compliance with Food and Drug 
Administration regulations and guidance documents or action levels.
    (b) Processing and production records showing adherence to scheduled 
processes, including records of pH measurements and other critical 
factors intended to ensure a safe product, shall be maintained and shall 
contain sufficient additional information such as product code, date, 
container size, and product, to permit a public health hazard evaluation 
of the processes applied to each lot, batch, or other portion of 
production.
    (c) All departures from scheduled processes having a possible 
bearing on public health or the safety of the food shall be noted and 
the affected portion of the product identified; these departures shall 
be recorded and made the subject of a separate file (or log identifying 
the appropriate data) delineating them, the action taken to rectify 
them, and the disposition of the portion of the product involved.
    (d) Records shall be maintained identifying initial distribution of 
the finished product to facilitate, when necessary, the segregation of 
specific food lots that may have become contaminated or otherwise unfit 
for their intended use.
    (e) Copies of all records provided for in paragraphs (b), (c), and 
(d) of this section shall be retained at the processing plant or other 
reasonably accessible location for a period of 3 years from the date of 
manufacture.

[44 FR 16235, Mar. 16, 1979, as amended at 65 FR 56479, Sept. 19, 2000]