| Public Health Service Food and Drug Administration |
| Central Region Waterview Corporate Center 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 Telephone (973) 331-4908 |
Department of Health and Human Services
November 17, 2011
WARNING LETTER
VIA UPS OVERNIGHT
Mr. Barry Silberstein
President/Owner
B A Howie Inc.
77 Brooklyn Terminal Market
Brooklyn, New York 11236
File No.: 12-NWJ-03
Dear Mr. Silberstein:
The Food and Drug Administration conducted an inspection of your pickle manufacturing facility, located at 2660 Main Road, Franklinville, NJ, from August 8 through August 11, 2011. The inspection revealed serious violations of FDA's Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These conditions cause the pickles produced at your facility to be adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act) in that they have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.
1. You did not take all reasonable precautions to ensure that production procedures do not contribute to contamination from any source as required by 21 CFR 110.80. For example:
a. A loose stringy substance was observed at the gaskets of the lids that were to be used on the 48 and 55 gallon pickling barrels. The gaskets appeared to be degraded and it was determined that the stringy substance was "contact cement", a glue that is not intended for use as a food contact surface.
b. The wooden interior surface of the hopper, the slide doors, and the chutes used to fill barrels with cucumbers were worn, chipped, and splintered. In this condition, pieces of wood could contaminate product.
c. A splintered wooden plank was observed above the brine tanks to act as a "shelf' when adding bagged ingredients of raw materials into the tanks. This process could introduce wooden splinters into the product.
2. Your firm failed to store toxic materials in a manner that protects against the contamination of food as required by 21 CFR 110.35(b)(2). Specifically, paint thinner and contact cement were stored approximately two to three feet above and approximately four to five feet behind and to the side of pallets of bagged and/or boxed dry raw ingredients. such as spices. The presence of a potentially dangerous chemical in the immediate vicinity of food preparation areas creates a potential for product contamination with the toxic substance.
3. Your hand washing facilities lacked running water at a suitable temperature as required by 21 CFR 110.37(e) and were not adequate, in that, they lacked sanitary towels or a suitable drying device as required by 21 CFR 110.37(e)(3).
4. You did not maintain buildings fixtures or other physical facilities in a sanitary condition as required by 21 CFR 110.35(a). Specifically, the approximately (b)(4) square foot cooler had areas of pooling liquid and mud on the floor. Product is (b)(4) in this cooler during the (b)(4) process and during storage; therefore, there is the potential for product contamination to occur.
5. You did not adequately drain areas which may contribute to contamination of food by foot-borne filth and providing a breeding place for pests as required by 21 CFR 110.20(a)(3). Specifically, facility grounds at the production entrance ramp to the cooler lack adequate soil grading resulting in pooling water. As a result of the pooling water, mud is being brought into the approximately (b)(4) square foot cooler from the forklifts used to transport full pickling barrels from the nearby processing/storage pavilion into the cooler. This is a repeat observation from a November 20, 2009 inspection that was not corrected by your firm.
6. You did not remove litter and waste and cut weeds or grass that may constitute an attractant, breeding place or harborage for pests within the immediate vicinity of the plant buildings or structures as required by 21 CFR 110.20(a)(1). For example, approximately (b)(4) of (b)(4) acres of your property had inadequately maintained grounds. The grounds were overgrown with weeds and uncut grass and held old, unused equipment. The area closest to the brining tanks, production entrance ramps, and loading docks had an accumulation of litter and debris providing nesting material and affording harborage for pests. This is a repeat observation from a November 20, 2009 inspection that was not corrected by your firm.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be addressed to U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054, Attn: Kerry Kurdilla, Compliance Officer.
Sincerely,
/S/
Diana Amador-Taro
District Director
New Jersey District
cc:
Mr. Scott Silberstein, Vice President
B A Howie Inc.
77 Brooklyn Terminal Market
Brooklyn, NY 11236
Mr. Steve Vitti, General Manager
B A Howie Inc.
2660 Main Road
Franklinville, NJ 08322
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