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U.S. Department of Health and Human Services

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Enforcement Actions

Perez Ident Peppers 7/14/09

   

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Southwest Import District
4040 North Central Expressway
Suite 300
Telephone: 214-253-5200
Fax: 214-253-5316

 


July 14, 2009


WARNING LETTER


FY-09-SWID-WL-002


VIA FEDERAL EXPRESS


Mr. Luis M. Perez
125 N. Stevens St.
El Paso, TX 79905-1228


Dear Mr. Perez


We inspected your food distribution warehouse, located at 125 N. Stevens St., El Paso.
TX, on April 14-24, 2009.  Our findings revealed deviations from the Current Good
Manufacturing Practices in Manufacturing, Packing or Holding Human Foods
Regulations, Title 21, Code of the Federal Regulations. Part 110 (21 C.F.R. 110). By
virtue of these deviations, the products at processed at your firm's facility are adulterated
within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the
Act) [21 U.S.C. 342(a)(4)] because they have been prepared, packed or held under
insanitary conditions whereby it may have become contaminated with filth, or whereby
they may have been rendered injurious to health. You may find the Act and the
regulations through links in the FDA's Internet home page at www.fda.gov.

 

At the conclusion of the inspection, investigators provided you with a Form FDA 483
which presents the evaluation of your firm's performance regarding various aspects of
your food facility's receipt and distribution of fresh fruits and vegetables as well as
repacking of dried peppers and corn husk. A number of deviations were listed on the
Form FDA 483, including the following:


1. All food-contact surface must be cleaned a frequently a necessary to protect
against contamination of food. [21 C.F.R. § 110.35(d)].


Dirty utensils and remnants of assorted fruits and vegetables were observed on the
surface of a metal sorting table located in the southeast corner of the warehouse.
The table also had several layers of an unidentified, black material.


2. All plant equipment and utensils shall be so designed and of such material and
workmanship as to be adequately cleanable, and shall be properly maintained.
[21 C.F.R. § 110.40(a)].


A wooden sorting table with a rough, unfinished wooden surface in a processing,
area common to both Perez Ident Peppers and Superior Fruit and Vegetable, near
the west/southwest corner of the warehouse, was being used to sort fresh poblano.
The surface of the table was observed to be discolored and encrusted with several
layers of buildup of a dark, unknown substance.


3. Buildings, fixtures, and other physical facilities of the plant shall be maintained in
a sanitary condition. [21 C.F.R. § 110.35(a)].


a. A thick gray mold-like substance was observed growing in various locations
in cold storage unit #5 located along the western wall in the northwest comer
of the facility. The mold-like substance was growing on decaying plant matter,
which was on a cement ledge near the floor, in close proximity to fresh, ready-to-eat
produce.


b. In the common storage area along the south Wall, several uncovered, used
trailer tires stored directly above the open boxes of fresh onions were observed.


c. Units 3, 4, and 5 contained covered fluorescent light fixtures with thick black
spots of an unknown substance on all surfaces of each fixture and surrounding
areas of the ceiling, directly over fresh ready-to-eat product.


4. The plant must be constructed in such manner as to prevent condensate from
contaminating food or food-contact surfaces. [21 C.F.R. § 110.20(b)(4)].


We observed in cold storage units 3, 4, and 5 located along the western/north
western wall of the facility, pallets of fresh produce stored under large cooling
units. These units were observed to have layers of grime and particulate matter
encrusted on the housing and fan blades. The units were equipped with pans and
plumbing to capture and drain condensate. However, it was observed that in all
units condensate drained directly onto the floor of each unit resulting in pools of
standing Water under and around pallets of fresh produce.


5. Rubbish and any offal shall be conveyed, stored, and disposed of as to minimize
the development of odor, minimize the potential for the waste becoming an
attractant and harborage or breeding place for pests, and protect against
contamination of food and food-contact surfaces. [21 C.F.R. § 110.37(f)]


We observed in storage units 3, 4, and 5 decaying plant like material and
filth compacted in corners and crevices. 

6. Employees shall be provided with adequate toilet facilities. This may be
accomplished in part by the toilet facilities in a sanitary condition and
providing doors that do not open into areas where food is exposed. [21 C.F.R. §
110.37 (d)].


The employee restroom located centrally in the facility, adjacent to the stairs in
the large common areas, was observed with the door open and approximately ten
feet from fresh food products. A large utility sink directly adjacent to the
employee bathroom and within approximately six feet of ready to eat food
products contained a blue plastic bucket full of dark, dirty water and a used mop.


7. You must confine the eating of food and the drinking of beverages to areas other
than where food may be exposed. [21 C.F.R.  § 110.10(b)(8)].


a. Two employees were observed sorting poblano peppers while eating their
lunch and drinking beverages in the southwest corner of the facility. Their
lunch was sitting on the encrusted wooden sorting table as they worked
with the fresh product on the same table.


b. Condiments packages were observed on the surface of a metal sorting
table located in the southeast corner of the warehouse.


8. All persons working in direct contact with food, food contact surfaces, and food
packaging materials must wear outer garments suitable to the operation in a
manner that protects against the contamination of food, food-contact surfaces, or
food packaging material. [21 C.F.R. § 110.10(b)(1)].


The two employees who were observed sorting poblano peppers while eating their
lunch were not wearing any garments suitable for food handling operation nor
were they using protective gloves.


The above violations are not meant to be an all-inclusive list of deficiencies in your
facility. It is your responsibility to ensure that all of your products are in compliance
with applicable laws and regulations. You should take a prompt action to correct all of
the violations noted in this letter. Failure to promptly correct these deviations may results
in regulatory actions including seizure and/or injunction without further notice.

Please respond in writing within 15 working days of your receipt of this letter outlining
the specific steps you have taken to bring your firm into compliance with the law. Your
response should include each step taken to correct the violations and prevent their
recurrence. If you can not complete all corrections within 15 working days, we expect
you to explain the reason for the delay and state when any remaining deviations will be
corrected. 


Please send your reply to U.S. Food and Drug Administration, Attention: Rosa Linda
Santos, Compliance Officer, at the following address: 1777 N. Frank Reed Road,
Nogales, AZ 85621. If you have questions regarding the issues in this letter, please
contact Compliance Officer Santos at 520-281-1100 Ext 102.


Sincerely,

/S/
Robert J. Deininger
District Director


cc: WL File
HFR-SW650 (SWID DIB)
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