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WARNING LETTER

Gasco Industrial


Recipient:
Gasco Industrial


United States

Issuing Office:
San Juan District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 San Juan District
Compliance Branch
466 Fernández Juncos
San Juan, Puerto Rico 00901
 
Telephone: (787) 729-8500
FAX: (787) 729-8765

 

February 11, 2016
 
WARNING LETTER
 
16-SJN-WL-06
 
UPS NEXT DAY DELIVERY SERVICE
SIGNATURE REQUIRED
 
 
Mr. Dan N. Bigman
Owner and VP of Quality
Gasco Industrial Corp.
PO Box 1360
Gurabo, Puerto Rico 00778-1360
 
Dear Mr. Bigman:
 
An inspection of your food manufacturing facility located at Calle A Lote 3 Rincon Industrial Park, Gurabo, Puerto Rico, was conducted on October 9, 13, and 22, 2015, by Investigators of the United States Food and Drug Administration (FDA). Our investigators observed significant violations within the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR part 110) regulations, which cause the food products that you manufacture to be 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)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or may have been rendered injurious to health. You can find the Act and the CFR through links on FDA’s home page at http://www.fda.gov
 
At the conclusion of the inspection, the investigators issued an FDA-483 form, Inspectional Observations that listed the deviations found at your firm. At the end of the inspection, you promised to make corrections; however, to date we have not received a response with corrections from your firm.
 
We observed the following insanitary conditions and practices:
 
1.     Your firm failed to take effective measures to exclude pests from processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). In addition, your firm failed to provide adequate screening or other protection against pests, as per 21 CFR 110.20(b)(7).  During current inspection, the investigators observed what appears to be live cockroaches, too numerous to count, coming from a wooden pallet located next to the (b)(4) used to manufacture seasonings. The cockroaches scattered throughout the seasonings production room as the pallet was moved. In addition, a live cockroach was observed in the hand-washing station in the women’s toilet facility. Also, gaps to the exterior premises were observed throughout the facility, as well as missing, damaged and/or detached windows screens which facilitate entry of pests. We are concerned with your continued inability to take effective measures to exclude pests. This is a repeat observation disclosed during previous US FDA inspections (for example, inspections conducted in 2010, 2011 & 2012).
 
2.     Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food-contact surfaces, as per 21 CFR 110.35(a).  During current inspection, it was observed that your firm’s current practice is to clean the equipment by (b)(4). However, your firm failed to demonstrate that current practice includes sanitizing food-contact surfaces as defined on 21 CFR 110.3(o).  We are concerned with your continued inability to adequately establish cleaning and sanitizing operations.  This is a repeat observation disclosed during previous US FDA inspections (for example, inspections conducted in 2010, 2011, 2012, & 2013).
 
3.     Lack of effective hand cleaning and sanitizing preparations, as per 21 CFR 110.37(e)(2).  For example, the hand-washing station located in the production area, lacked soap or any other cleaning/sanitizing preparation for the employees to wash their hands before engaging in any processing operations. This is a repeat observation from a previous US FDA inspection conducted in 2010.
 
4.     Failure to provide safety-type lighting fixtures suspended over exposed food, as per 21 CFR 110.20(b)(5).  For example, the lamp fixtures located in the raw materials receiving area and inside the seasoning production room were not equipped with protective covers.  The investigators observed a lamp fixture without any protective cover located in the seasonings’ production room on top of uncovered transfer carts. This is a repeat observation disclosed during previous US FDA inspections (for example, inspections conducted in 2011 & 2012).
 
This letter may not list all the violations at your facility.  You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA.  You should take prompt action to correct these violations.  Failure to promptly correct these violations may result in regulatory action by FDA without further notice.  Such action includes seizure of your products and/or injunction.
 
Further, Section 743 of the Act (21 U.S.C. § 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs.  A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the inspection and assessing and collecting the inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should respond in writing within 15 working days from receipt of this letter. Your response should outline the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent their recurrence. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
 
Your reply should be directed to Ms. Maridalia Torres, District Director, Food and Drug Administration, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223.  If you have any questions regarding this letter, please contact Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or marilyn.santiago@fda.hhs.gov. 
 
Sincerely,
/S/
Maridalia Torres
District Director
San Juan District