21cfr1271

§ 1271.370

21 CFR Ch. I (4–1–06 Edition)

be taken in response to the HCT/P deviation (e.g., recalls).
(3) You must report each such HCT/P
deviation that relates to a core CGTP
requirement on Form FDA–3486 available at http://www.fda.gov/cber/biodev/
bpdrform.pdf, within 45 days of the discovery of the event either electronically at http://www.fda.gov/cber/biodev/
biodevsub.htm or by mail to the Director, Office of Compliance and Biologics
Quality, Center for Biologics Evaluation and Research (HFM–600), 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448.
§ 1271.370

Labeling.

The following requirements apply in
addition to §§ 1271.55, 1271.60, 1271.65,
and 1271.90:
(a) You must label each HCT/P made
available for distribution clearly and
accurately.
(b) The following information must
appear on the HCT/P label:
(1) Distinct identification code affixed to the HCT/P container, and assigned in accordance with § 1271.290(c);
(2) Description of the type of HCT/P;
(3) Expiration date, if any; and
(4)
Warnings
required
under
§ 1271.60(d)(2),
§ 1271.65(b)(2),
or
§ 1271.90(b), if applicable and physically
possible. If it is not physically possible
to include these warnings on the label,
the warnings must, instead, accompany
the HCT/P.
(c) The following information must
either appear on the HCT/P label or accompany the HCT/P:
(1) Name and address of the establishment that determines that the HCT/P
meets release criteria and makes the
HCT/P available for distribution;
(2) Storage temperature;
(3) Other warnings, where appropriate; and
(4) Instructions for use when related
to the prevention of the introduction,
transmission, or spread of communicable diseases.
[69 FR 68686, Nov. 24, 2004, as amended at 70
FR 29952, May 25, 2005]

Subpart F—Inspection and Enforcement of Establishments
Described in § 1271.10
SOURCE: 69 FR 68687, Nov. 24, 2004, unless
otherwise noted.

§ 1271.390

Applicability.

The provisions set forth in this subpart are applicable only to HCT/Ps described in § 1271.10 and regulated solely
under section 361 of the Public Health
Service Act and the regulations in this
part, and to the establishments that
manufacture those HCT/Ps. HCT/Ps
that are drugs or devices regulated
under the act, or are biological products regulated under section 351 of the
Public Health Service Act, are not subject to the regulations set forth in this
subpart.
§ 1271.400

Inspections.

(a) If you are an establishment that
manufactures HCT/Ps described in
§ 1271.10, whether or not under contract,
you must permit the Food and Drug
Administration (FDA) to inspect any
manufacturing location at any reasonable time and in a reasonable manner
to determine compliance with applicable provisions of this part. The inspection will be conducted as necessary in
the judgment of the FDA and may include your establishment, facilities,
equipment, finished and unfinished materials, containers, processes, HCT/Ps,
procedures, labeling, records, files, papers, and controls required to be maintained under the part. The inspection
may be made with or without prior notification and will ordinarily be made
during regular business hours.
(b) The frequency of inspection will
be at the agency’s discretion.
(c) FDA will call upon the most responsible person available at the time
of the inspection of the establishment
and may question the personnel of the
establishment as necessary to determine compliance with the provisions of
this part.
(d) FDA’s representatives may take
samples, may review and copy any
records required to be kept under this
part, and may use other appropriate

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