explain why you need to follow these rules recall rules
Answers
A product recall is defined as a request to return, exchange, or replace a product after a manufacturer or consumer watch group discovers defects that could hinder performance, harm consumers, or produce legal issues for the producers.
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Answer:
CDRH will assign a recall number and issue a classification memo to the division and
the Press Office when the corrective action plan (CAP) and an approval letter is signed
and issued to the recalling firm. CDRH will send copies of the CAP approval letter, the
corrective action plan and the letter of non-compliance with the classification memo.
The home division will then promptly obtain from the firm by phone or a visit any other
information required for the Enforcement Report and the Initial Recall Notification
message to the field. This will not affect the way the division processes recalls for X-ray
assemblers and suntan lamp recalls. The home district office or division will still
continue to submit a Recommendation for Recall for cases generated in the field. The
division s will approve the corrective action plans for these cases, and submit a copy of
the division approval letter with the Recommendation for Recall to CDRH for issuance
of a recall number.
The timeliness of audit check issuance will depend on the progress of the CAP and may
be determined by recall status reports received from the firm. Audit checks should issue
when the recall is approximately 25% complete and continue throughout the completion
of the recall. At the point when the recalling firm indicates by way of their status reports
to the division that they have completed the recall action at 25% of their consignees, the
field will issue a request for a portion of the required audit checks to affected divisions.
Upon receipt of the completed audit check reports from the divisions, the lead Recall
Coordinator will evaluate the audit checks to determine if the recall is effectively on-
going. If apparently effective, the balance of the audit checks need not be requested
until the recall is complete, or nearly so. Center consultation is available, if needed, in
determining the effectiveness of the recall at the 25% complete mark.
The recalling firm must, in its CAP, provide a target date for completing the recall. The
time span is typically six months to one year. If the firm does not or is not likely to
complete the recall within the specified time, a Warning Letter should be issued to the
firm. The firm may request a time extension to complete the recall. All such requests
must be approved by CDRH.
If a request for extension is denied, the home division will send the firm a warning letter
when the target completion date expires.
The division will document unsatisfactory results of a CAP and/or other violations of
Subchapter C by inspection and field testing. Bimonthly recall status reports will