IA#25-15, ----7/10/92
TYPE OF ALERT: Automatic Detention
PRODUCT : Canned Mushrooms, (common mushrooms species, Agaricus only),
all can sizes and all product styles.
PRODUCT CODE : 25PEE___ or
25REE___ or 25QEE___
HARMONIZED
CODE : (2003)
PROBLEM : Staphylococcal Enterotoxin (FLST)
COUNTRY : Taiwan (TW, 281)
MANUFACTURER/
SHIPPER : Hwa Chen YuanLin Cannery
10, Lane 6, Sec. 1, Chung Shan Road
YuanLin 501, Taiwan
FCE No. 05120
MANUFACTURER/
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. # : N/A
CHARGE : "The article is subject to refusal of admission pursuant to
Section 801(a)(1) in that it appears to have been prepared,
packed or held under insanitary conditions whereby it may have
been rendered injurious to health [Adulteration, 402(a)(4)]."
RECOMMENDING
OFFICE : CFSAN, Division of Regulatory Guidance, HFF-310
REASON FOR
ALERT : Industry sources reported to FDA that their analysis found
staphylococcal enterotoxin in two production codes
manufactured by the Hwa Chen YuanLin Cannery. FDA
subsequently confirmed the presence of staphylococcal
enterotoxin in previously unopened cans from both production
codes supplied by the industry sources. Both production codes
found contaminated were 4oz. cans.
The presence of staphylococcal enterotoxin can only occur when
there has been gross mishandling of the product, which would
allow for the growth of the microorganism, and can be
associated with insanitary conditions during harvesting,
transporting, or processing. These conditions are likely to
exist on any given day and contamination would not be
restricted to particular can sizes or product styles. Until
the cause of contamination can be identified, it appears that
any code lot, regardless of can size or product style,
produced by the manufacturer may be contaminated with
staphylococcal enterotoxin and represent a potential danger to
public health.
INSTRUCTIONS : Automatically detain all can sizes and product styles of
mushrooms packed by the manufacturer; because this is a
potential health hazard, Any Entries Which Have Not Been
Released Are Subject To This Alert. Samples should be
collected for staphylococcal enterotoxin analysis on as many
entries as possible from other Taiwan manufacturers/shippers.
Because this alert is issued pursuant to 801(a)(1), no
reconditioning will be permitted.
FDA will consider removal from automatic detention when the
manufacturer has documented all of the following: 1) the
source of contamination; 2) appropriate control procedures
which have been instituted to preclude contamination of the
mushrooms with staphylococcal enterotoxin; 3) compliance with
21 CFR 108.35 and 113.
Any request for removal from automatic detentions, or other
inquiries regarding this Import Alert should be referred to
CFSAN/DRG, HFF-310.
To assure the effectiveness of the automatic detention, this
firm will be listed in Import Alert #99-04.
PRIORITIZATION
GUIDANCE : I
FOI : No purging required.
KEYWORDS : Mushrooms, Staphylococcal Enterotoxin, Taiwan, China, Canned
Mushrooms, Hwa Chen YuanLin Cannery.
PREPARED BY : John Browne, DIOP, 301-443-6553.
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