[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR114.100]
[Page 262]
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]
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