[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.260]

[Page 199]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 107--INFANT FORMULA--Table of Contents
 
                    Subpart E--Infant Formula Recalls
 
Sec. 107.260  Revision of an infant formula recall.

    If after a review of the recalling firm's recall strategy or 
periodic reports or other monitoring of the recall, the Food and Drug 
Administration concludes that the actions of the recalling firm are 
deficient, the agency shall notify the recalling firm of any serious 
deficiency. The agency may require the firm to:
    (a) Change the extent of the recall, if the agency concludes on the 
basis of available data that the depth of the recall is not adequate in 
light of the risk to human health presented by the infant formula.
    (b) Carry out additional effectiveness checks, if the agency's 
audits, or other information, demonstrate that the recall has not been 
effective.
    (c) Issue additional notifications to the firm's direct accounts, if 
the agency's audits, or other information demonstrate that the original 
notifications were not received, or were disregarded in a significant 
number of cases.