| Public Health Service Food and Drug Administration |
Los Angeles District |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
February 14, 2011 W/L 25-11
Martin L. Morhar, President
A-1 Eastern Homade Pickle Co, Inc.
1832 Johnston St,
Los Angeles, CA, 90031-3447
Dear Mr. Morhar,
The Food and Drug Administration (FDA) inspected your processing facility, located at 1832 Johnston Street, Los Angeles, California on November 8 - 10, 2010. FDA investigators documented serious violations of the Current Good Manufacturing Practice regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).
Based on your failure to comply with the requirements of the Current Good Manufacturing Practice (CGMP) regulation in 21 CFR Part 110, we have determined that your food products 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)]. You may find the Act and the CGMP regulations through links on FDA's home page at www.fda.gov.
The inspectors' observations were presented to you on an FDA-483 at the conclusion of our inspection on November 10, 2010. The significant violations documented during the inspection include the following:
1. You failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests. [21 CFR 110.35(c)]. Specifically,
a) Flying insects were observed landing directly on dill pickles stored in open totes located in your storage shed.
b) Eight flying insects were observed in the processing room during the production of relish.
c) Six flying insects were observed landing directly on exposed pickles staged outside pending processing.
2. You failed to provide adequate screening or other protection against pests. [21 CFR 110.20(b)(7)]. Specifically,
a) Your firm's storage shed screening is not adequately constructed to prevent pests from entering because the mesh is large enough to allow flies into the facility.
b) Your firm's processing room door remained open throughout production without any screening or other pest protection.
3. You failed to inspect and segregate or otherwise handle raw materials and other ingredients as necessary to ascertain that they are clean and suitable for processing into food and failed to store raw materials and other ingredients under conditions that will protect against contamination and minimize deterioration. [21 CFR 110.80(a)(1)]. Specifically,
a) On November 9, 2010, you received a shipment of 19 totes of fermented cucumbers from your supplier (b)(4). All 19 totes of fermented cucumbers were observed to be shipped, received and stored with no cover, leaving them open and exposed to contamination.
b) Fermented pickles were stored stacked one on top of the other in open totes. The bottom surfaces of these stacked totes are rough, in disrepair, and heavily soiled.
c) A plastic tarp used to cover bulk totes of dill pickles and dill chips was soiled, punctured, and partially submerged in dill pickles.
4. You failed to properly maintain plant equipment and utensils. [21 CFR 110.40(a)]. Specifically,
a) Three conveyor belts used to process ready to eat pickle products were frayed, torn, shredded, and stained. In addition, these conveyor belts were held together with a metal staple-like seam. There was a build up of residue between staples and missing staples.
b) Nets constructed of absorbent materials were in direct contact with pickled cucumbers and peppers during processing and packaging. These nets were frayed and had pickle residue embedded in them prior processing.
c) Various frame sections of your pickle conveyor lines and packing line were repaired with rubber bands, plastic zip ties, plastic wrap, a rusted metal C-clamp, and rusted vice grip-like tools.
d) Vats 1, 2, and 3 were equipped with a metal hinged cover. The metal hinges allow water to drip into the product. FDA inspectors observed visibly soiled water drip through the metal hinges onto whole dill pickles. In addition, one of the covers was observed to be cracked.
e) A hole at the base of Vat 1 was plugged with visibly soiled plastic wrap.
f) The sealant/patching inside of Vat 2 and Vat 3 was observed to be peeling.
5. You failed to have smoothly bonded or maintained seams on food contact surfaces, in order to minimize accumulation of food particles, dirt, and organic matter and the opportunity for growth of microorganisms. [21 CFR 110.40(b)]. Specifically, multiple food contact surfaces in your processing room had poorly bonded seams and/or rough welds. Food residues and rust were observed to be embedded in these seams and welds prior to the start of operation on November 9, 2010. These food contact surfaces include conveyor belt frames, the dill chip shaker, and the blades of the relish mixer.
6. You failed to perform packaging in a manner that protects food against contamination. [21 CFR 110.80(b)(13)]. Specifically,
a) On November 9, 2010, an employee in the packaging room was observed touching various soiled surfaces including the frame of the packing line conveyor with his gloves, and then the employee was observed directly handling dill pickles as they were pushed into plastic jars. This employee did not change or wash the soiled gloves prior to handling in process pickles.
b) On November 9, 2010, three dill pickle jar lids were observed to have fallen onto the wet packaging room floor. An employee picked these lids up off the floor and placed them directly back into an in-use box of lids.
7. You failed to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food. [21 CFR 110.35(d)]. Specifically, our inspection found the following conditions prior to production on November 9, 2010:
a) Pickle slices were wedged into a conveyor belt frame.
b) Dried cucumber seeds and pickle residue were observed on conveyor belts, the dill pickle shaker, multiple rotary cutter blades and on the relish auger box and screen.
c) Pickle residues and sauerkraut were observed on the packaging line.
d) The inside covers of Vat 2 and Vat 3 had a build up of apparent mold and debris.
e) Recycled kegs used to pack bulk food products for delivery were not washed. The kegs were rinsed with only water in between uses.
8. You failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food-contact surfaces. [21 CFR 110.35(a)]. Specifically, our inspection found the following on November 9, 2010:
a) An employee placed the lid to Vat 2 directly on the floor during cleaning.
b) Water from the use of a hose splashed from the floor directly onto the food contact surfaces of plastic bag liners in kegs that were staged for packing.
9. You failed to maintain buildings and keep them in repair sufficient to prevent food from becoming adulterated. [21 CFR 110.35(a)]. Specifically,
a) Two windows in your processing room had broken/cracked glass. These broken/cracked windows were located near the first pickle conveyor belt and the fermented cucumbers cooking vats.
b) Peeling paint and mold were observed on the ceiling in your processing room directly above exposed dill chips at the dill chip shaker.
10. You failed to adequately install and maintain plumbing of adequate size and design to avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition. [21 CFR 110.37(b)(3)]. Our inspection found one hose in your processing room and two hoses in your packaging room used to rinse your processing/packing equipment and bulk packaging did not have any backflow prevention devices installed. The open end of at least one hose was observed lying on the processing room floor.
On November 15, 2010, FDA verified that you voluntarily had covered all open and exposed totes that are used to hold fermented cucumbers in brine. We acknowledge that you voluntarily destroyed 20 totes/40,000 lbs. of fermented cucumbers soaking in brine which exhibited flying insects on and/or near them while they were previously stored open and exposed in the firm’s storage warehouse shed.
We received your written response to the FDA Form 483, which was dated December 14, 2010 and received on December 17, 2010. We do not address that response because it arrived more than 15 working days after the close of the inspection. Consistent with FDA’s federal register notice of August 11, 2009 announcing its program to facilitate the timely issuance of warning letters (74 FR 40211-12), FDA will evaluate your December 14, 2010 response along with any response to this warning letter.
The above violations are not intended to be an all-inclusive list of violations in your plant. You are responsible for ensuring that you manufacture products in compliance with the Act and all of its implementing regulations, including the CGMP regulations (21 CFR Part 110). You are also responsible for using procedures to prevent further violations of the Act, all applicable regulations, and all other requirements of federal law.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action of violations may result in regulatory action being initiated by FDA without further notice. For example, we may seize your products and/or enjoin your firm from operating.
You should notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long-term, corrective action, such as training logs. If you cannot complete all corrections before you respond, you should explain the reason for the delay and include a timetable for the implementation of any remaining corrections.
Please send your response to the Food and Drug Administration, attention:
Blake Bevill
Director, Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 858-550-3850 x106.
Sincerely,
/s/
Alonza E. Cruse
District Director
Los Angeles District
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