Inspections, Compliance, Enforcement, and Criminal Investigations
Gold Coast United, Inc. 10/15/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
October 15, 2012
Return Receipt Requested
Mr. Siu Ming Leung, President
Gold Coast United, Inc.
6650 Santa Barbara Road, Suite 6
Elkridge, MD 21075
Dear Mr. Leung:
The Food and Drug Administration (FDA) inspected your manufacturing facility located at 6650 Santa Barbara Road, Suite 6, Elkridge, Maryland, from June 1, 2012 through June 12, 2012. The inspection revealed insanitary conditions and serious violations of Title 21 of the Code of Federal Regulations (CFR) Part 110 – Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation. Because your tofu and soy milk products have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health, your tofu and soy milk 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 FDA’s regulations through links in FDA’s home page at www.fda.gov. The violations include, but are not limited to, the following:
1. Employees at your firm failed to wash and sanitize hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any time their hands may have become soiled or contaminated. [21 CFR 110.10(b)(3)] Specifically, none of the food handling employees were observed washing or sanitizing their hands and arms while leaving the processing room on multiple occasions, touching the discolored strip curtains, and handling various equipment and utensils, before coming into direct contact with raw and ready-to-eat (RTE) tofu and soy milk. In addition, a food handling employee was observed submerging his bare arms, including portions of his arms not covered by his disposable vinyl gloves, into the RTE tofu cooling tank, without washing or sanitizing his hands or arms beforehand. [FDA-483 observation 2]
2. Gloves used in food handling are not maintained in an intact, clean, and sanitary condition. [21 CFR 110.10(b)(5)] Specifically, none of the food handling employees were observed washing and/or sanitizing their re-usable latex gloves while leaving the processing room on multiple occasions, after touching the discolored strip curtains, handling various equipment and utensils, and coming into direct contact with raw and RTE tofu and soy milk. [FDA-483 observation 3]
3. Your firm failed to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives. [21 CFR 110.40(a)] Specifically, food handling employees
were observed using three plastic, rectangular tools to stir RTE soy milk, and to measure and slice RTE blocks of tofu. All three tools had a yellowish discoloration and gouges, too numerous to count, covering their entire surfaces. [FDA-483 observation 4]
4. Your firm failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food contact surfaces. [21 CFR 110.35(a)] Specifically, a food handling employee was observed using a metal paddle to stir raw soy beans in a 55-gallon container, after he cleaned the paddle by putting it on the floor and rinsing it solely with hose water. [FDA-483 observation 6]
We have received your correspondence dated June 27, 2012, submitted in response to the FDA-483, Inspectional Observations; it will be made part of our official files. We have reviewed your response and find the corrective actions, in general, to be isolated to the observations on the FDA-483. However, the response does not address the underlying causes of the deviations. Your response did not include sufficient information to enable us to assess whether your firm has effectively implemented its proposed corrective actions or whether those corrective actions will adequately address the underlying causes of the deviations described above.
The deviations identified above are not intended to be an all-inclusive list of deficiencies at your establishment. It is your responsibility to ensure that all products marketed by your firm comply with the FD&C Act and its implementing regulations. You must take prompt action to correct these violations. Failure to promptly correct these deviations may result in administrative and/or regulatory action without further notice including, but not limited to, seizure, injunction, and/or prosecution.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Ms. Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Compliance Officer Cherlita Honeycutt at (410) 779-5412 or via e-mail at Cherlita.Honeycutt@fda.hhs.gov.
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