0256 21cfr106

§ 106.90

21 CFR Ch. I (4–1–06 Edition)

the vitamin D bioassay and, if required, a protein biological quality bioassay are complete, provided such bioassays have been initiated, and if another analysis for the vitamin D has
been run and the protein content has
been determined by a suitable method.
The biological quality of the protein
shall be determined by an appropriate
modification of the AOAC bioassay
method of analysis. The manufacturer
shall analyze additional samples from
the same batch for vitamin D, by any
suitable method, and for the biological
quality of the protein. The manufacturer shall perform such analyses at
least annually for a period not to exceed the expected shelf life of the product.
(d) A simple adjustment in the level
of an ingredient to accommodate inconsistencies in processing is considered to be neither a minor nor a major
change.
[47 FR 17025, Apr. 20, 1982, as amended at 54
FR 24891, June 12, 1989; 63 FR 14035, Mar. 24,
1998]

§ 106.90

Coding.

The manufacturer shall code all infant formulas in conformity with the
coding requirements that are applicable to thermally processed low-acid
foods packaged in hermetically sealed
containers as prescribed in § 113.60(c).

Subpart C—Records and Reports
§ 106.100

Records.

(a) Every manufacturer of infant formula shall maintain the records specified in this regulation in order to permit the Food and Drug Administration
to determine whether each manufacturer is in compliance with section 412
of the Federal Food, Drug, and Cosmetic Act (the act).
(b) The manufacturer shall maintain
all records that pertain to food-packaging materials subject to § 174.5 of this
chapter and that bear on whether such
materials would cause an infant formula to be adulterated within the
meaning of section 402(a)(2)(C) of the
act.
(c) The manufacturer shall maintain
all records that pertain to nutrient
premix testing that it generates or re-

ceives. Such records shall include, but
are not limited to:
(1) Any results of testing conducted
to ensure that each nutrient premix is
in compliance with the premix certificate and guarantee and specifications
that have been provided to the manufacturer by the premix supplier, including tests conducted when nutrients exceed their expiration date or shelf life
(retest date).
(2) All certificates and guarantees
given by premix suppliers concerning
the nutrients required by section 412(i)
of the act and § 107.100 of this chapter.
(d) The premix supplier shall maintain the results of all testing conducted to provide all certificates and
guarantees concerning nutrient premixes for infant formulas. Such records
shall include but are not limited to:
(1) The results of tests conducted to
determine the purity of each nutrient
required by section 412(i) of the act or
§ 107.100 of this chapter and any other
nutrient listed in the certificate and
guarantee;
(2) The weight of each nutrient
added;
(3) The results of any quantitative
tests conducted to determine the
amount of each nutrient certified or
guaranteed; and
(4) The results of any quantitative
tests conducted to identify the nutrient levels present when nutrient premixes exceed their expiration date or
shelf life (retest date).
(e) The manufacturer shall maintain
all records necessary to ensure proper
nutrient quality control in the manufacture of infant formula products.
Such records shall include the results
of any testing conducted to verify that
each nutrient required by section 412(i)
of the act or § 107.100 of this chapter is
present in each batch of infant formula
at the appropriate concentration. This
requirement pertains to ingredients, in
process batch and finished product
from the time of manufacture through
its expiration date.
(f) The manufacturer shall maintain
all records necessary to ensure required nutrient content at the final
product stage. Such records shall include, but are not limited to, testing
results for vitamins A, B1 (thiamine),

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Food and Drug Administration, HHS

§ 106.100

C, and E for each batch of infant formula. ‘‘Final product stage’’ means the
point in the manufacturing process
prior to distribution at which the infant formula is homogenous and not
subject to further degradation from the
manufacturing process.
(g) The manufacturer shall maintain
all records pertaining to distribution of
the infant formula. Such records shall
include, but not be limited to, all information and data necessary to effect
and monitor recalls of the manufacturer’s infant formula products in accordance with subpart E of part 107 of this
chapter.
(h) The manufacturer shall maintain
all records pertaining to the microbiological quality and purity of raw
materials and finished powdered infant
formula.
(i) [Reserved]
(j) The manufacturer shall maintain
all records pertaining to regularly
scheduled audits, including audit plans
and procedures. Audit plans identify
the specific manufacturing and quality
control procedures to be reviewed.
Audit procedures are the methods used
to review the manufacturing and quality control procedures. Records of audits shall include the information and
data necessary for a determination as
to whether the manufacturer complies
with the current good manufacturing
practices and quality procedures identified in parts 106, 107, 109, 110, and 113
of this chapter. The records shall include written assurances from the
manufacturer that regularly scheduled
audits are being conducted by appropriately trained individuals who do not
have any direct responsibility for the
manufacture or production of infant
formula, and that the complete audit
plans and procedures for the firm have
been followed. The actual written reports of the audits need not be made
available.
(k) The manufacturer shall maintain
procedures describing how all written
and oral complaints regarding infant
formula will be handled. The manufacturer shall follow these procedures and
shall include in them provisions for the
review of any complaint involving an
infant formula and for determining the
need for an investigation of the possible existence of a hazard to health.

(1) For purposes of this section, every
manufacturer shall interpret a ‘‘complaint’’ as any communication that
contains any allegation, written or
oral, expressing dissatisfaction with a
product for any reason, including concerns about the possible existence of a
hazard to health and about appearance,
taste, odor, and quality. Correspondence about prices, package size or
shape, or other matters that could not
possibly reveal the existence of a hazard to health shall not, for compliance
purposes, be considered a complaint
and therefore need not be made available to an FDA investigator.
(2) When a complaint shows that a
hazard to health possibly exists, the
manufacturer shall conduct an investigation into the validity of the complaint. Where such an investigation is
conducted, the manufacturer shall include in its file on the complaint the
determination as to whether a hazard
to health exists and the basis for that
determination. No investigation is necessary when the manufacturer determines that there is no possibility of a
hazard to health. When no investigation is necessary, the manufacturer
shall include in the record the reason
that an investigation was found to be
unnecessary and the name of the responsible person making that determination.
(3) When there is a reasonable possibility of a causal relationship between
the consumption of an infant formula
and an infant’s death, the manufacturer shall, within 15 days of receiving
such information, conduct an investigation and notify the agency as required in § 106.120(b).
(4) The manufacturer shall maintain
in designated files all records pertaining to the complaints it receives.
The manufacturer shall separate the
files into two classes:
(i) Those complaints that allege that
the infant became ill from consuming
the product or required treatment by a
physician or health-care provider.
(ii) Those complaints that may involve a possible existence of a hazard
to health but do not refer to an infant
becoming ill or the need for treatment
by physician or a health care provider.

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§ 106.120

21 CFR Ch. I (4–1–06 Edition)

(5) The manufacturer shall include in
a complaint file the following information concerning the complaint:
(i) The name of the infant formula;
(ii) The batch number;
(iii) The name of complainant;
(iv) A copy of the complaint or a
memo of the telephone conversation or
meeting and all correspondence with
the complainant;
(v) By reference or copy, all the associated manufacturing records and complaint investigation records needed to
evaluate the complaint. When copies of
such records are not maintained in the
complaint file, they must be available
within 24 hours when requested by an
FDA official.
(vi) All actions taken to follow up on
the complaint; and
(vii) All findings and evaluations of
the complaint.
(6) The manufacturer should maintain the files regarding infant formula
complaints at the establishment where
the infant formula was manufactured,
processed, or packed. When the manufacturer wishes to maintain all consumer complaints for the entire firm at
one location other than at the facility
where an infant formula was manufactured, processed, or packed, the manufacturer may do so as long as all
records required by this section are
available within 24 hours of request for
inspection at that facility. However,
all records of consumer complaints, including summaries, any reports, and
any files, maintained at the manufacturing facility or at any other facility
shall be made available to investigators for review and copying upon request.
(l) The manufacturer shall make
readily available for authorized inspection all records required under this
part or copies of such records. Records
shall be available at any reasonable
time at the establishment where the
activities described in such records occurred. (Infant formula complaint files
may be maintained at one facility, as
provided in § 106.100(k)(6), if all required
records are readily available at that facility.) These records or copies thereof
shall be subject to photocopying or
other means of reproduction as part of
such inspection. Records that can be
immediately retrieved from another lo-

cation by electronic means shall be
considered as meeting the requirements of this paragraph.
(m) Records required under this part
may be retained either as original
records or as true copies such as photocopies, microfilm, microfiche, or other
accurate reproductions of the original
records. Where reduction techniques,
such as microfilming are used, suitable
reader and photocopying equipment
shall be readily available.
(n) Production control, product testing, testing results, complaints, and
distribution records necessary to verify
compliance with parts 106, 107, 109, 110,
and 113 of this chapter, or with other
appropriate regulations, shall be retained for 1 year after the expiration of
the shelf life of the infant formula or 3
years from the date of manufacture,
whichever is greater.
(o) The manufacturer shall maintain
quality control records that contain
sufficient information to permit a public health evaluation of any batch of
infant formula.
[56 FR 66571, Dec. 24, 1991; 57 FR 7435, Mar. 2,
1992]

Subpart D—Notification
Requirements
§ 106.120 New formulations and reformulations.
(a) Information required by section
412(b)(2) and (3) of the act shall be submitted to Center for Food Safety and
Applied Nutrition (HFS–830), Food and
Drug
Administration,
5100
Paint
Branch Pkwy., College Park, MD 20740.
(b) The manufacturer shall promptly
notify the Food and Drug Administration when the manufacturer has knowledge (as defined in section 412(c)(2) of
the act) that reasonably supports the
conclusion that an infant formula that
has been processed by the manufacturer and that has left an establishment subject to the control of the manufacturer may not provide the nutrients required by section 412(g) of the
act and by regulations promulgated
under section 412(a)(2) of the act, or
when there is an infant formula that is
otherwise adulterated or misbranded
and that may present risk to human
health. This notification shall be made,

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