Mr. Ray Wu
- Nam & Nam, Inc. t/a Sam Sung Tofu
409 Morse Street, NE
- Issuing Office:
- Baltimore District Office
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Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707
CMS # 506791
January 24, 2017
Mr. Ray Wu, Owner
Nam & Nam, Inc. t/a Sam Sung Tofu
409 Morse Street, NE
Washington, DC 20002
Dear Mr. Wu:
The Food and Drug Administration (FDA) conducted an inspection of your firm, a manufacturer of tofu, located at 409 Morse Street, NE, Washington, DC 20002 from July 21, 2016 through August 10, 2016. During the inspection, FDA investigators observed significant violations of the Current Good Manufacturing Practices (CGMP) for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR part 110)
. Based on FDA’s inspectional findings, we determined that your firm’s tofu products manufactured at your facility are adulterated within the meaning of 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 been rendered injurious to health. Further, FDA reviewed the product labeling for your tofu products collected during the inspection and found significant violations of FDA’s food labeling regulation, Title 21, Code of Federal Regulations, Part 101(21 CFR part 101). These violations cause your foods to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov
Specifically, our inspection of your facility revealed the following violations:
1. You failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food-contact surfaces and food-packaging materials, as per 21 CFR 110.35(a). During the current inspection, it was observed that your firm uses Pyrene US 1021 and water to clean in place (CIP) your manufacturing equipment while no sanitizing step is performed at all during the cleaning process.
2. You failed to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination, as per 21 CFR 110.80(b)(2). During the current inspection, it was observed that your finished tofu product was measured to be 49.5 degrees Fahrenheit while being stored in your walk-in refrigerator. No monitoring of the refrigerator’s internal temperature was being performed.
3. You failed to provide adequate screening or other protection against pests, as per 21 CFR 110.20(b)(7). During the current inspection, it was observed that one (1) live apparent rat was observed on your firm’s floor underneath the three compartment sink in the production area, and apparent rodent excreta pellets too numerous to count were observed on the stairs of the storage area.
4. Your firm was observed using cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use, as per 21 CFR 110.35(b)(1). During the current inspection, it was observed that your firm is using an unmeasured amount of Pyrene US 1021 in recycled CIP water to clean equipment, utensils, tofu cloths, and other food contact surfaces. Pyrene US 1021 lists hazards such as, but not limited to “***Harmful by inhalation and if swallowed…Keep away from food and drink***”
5. Your firm’s Instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms are not adequately maintained, as per 21 CFR 110.40(f). During the current inspection, it was observed that your steam vat temperature gauge was in disrepair and not visible to determine temperature recordings.
6. Your firm’s plumbing constitutes a source of contamination to food, water supplies, equipment and utensils, as per 21 CFR 110.37(b)(3). During the current inspection, it was observed that your black hoses were being used to fill various containers with water while they were fully submerged underwater with no apparent air gap.
1. Your Sam Sung Tofu product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] in that the product label bears nutrient content claims, but the product does not meet the requirements to bear the claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling without complying with the specific requirement pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. For example:
- Your Sam Sung Tofu label bears a “Cholesterol Free” claim but fails to meet the requirements of 21 CFR 101.62(d)(i)(D), which states that if the food contains less than 2 mg of cholesterol per reference amount customarily consumed without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, then the product needs to be labeled to disclose that cholesterol is not usually present in the food (e.g., “applesauce, a cholesterol-free food”).
- In addition, your Sam Sung Tofu product bears a “Good Source of Protein” nutrient content claim. Under 21 CFR 101.13(n), nutrition labeling in accordance with 21 CFR 101.9 must be provided for any food for which a nutrient content claim is made. Under 21 CFR 101.9(c)(7)(i), a statement of the correct amount of protein per serving expressed as percent of Daily Value (DV) must be given if a protein claim is made for the product. However your Sam Sung Tofu product fails to provide the percent DV of protein as required under 21 CFR 101.9(c)(7)(i). Therefore, your product is misbranded under section 403(r)(1)(A) of the Act and section 403(q) of the Act [21 U.S.C. § 343(q)], because it does not provide information in accordance with 21 CFR 101.9(c)(7)(i) on the percent DV of protein for which a claim is made, as required under 21 CFR 101.13(n).
2. Your Sam Sung Tofu Label is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that all of the required nutrient information is not provided as specified under 21 CFR 101.9. Specifically, the product fails to declare the serving size in an appropriate common household measure. Furthermore, the serving size does not appear to be based on the appropriate reference amount customarily consumed (RACC). The reference amount for Tofu is 85g and not 255g. Therefore, we note that all nutrient amounts for this product may be incorrectly based on an incorrect serving size per 21 CFR 101.12.
3. Your 50 piece, bulk-packaged tofu is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the product label fails to declare the net quantity of contents in weight on the principal display panel as required by 21 CFR 101.7.
4. Your Sam Sung Tofu label is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] in that the product contains information in two languages, however, does not repeat all the required information in both languages. Specifically, we note that the language under 21 CFR 101.15(c)(1) states that "All words, statement, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in English language."
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products comply with the Act and FDA’s implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including, without limitation, seizure or injunction.
In addition we offer the following comments:
- Your 50 piece, bulk-packaged tofu product requires refrigeration however; the label fails to declare a “keep refrigerated” statement on the principal display panel. We suggest visiting FDA's Guidance on Labeling of Foods That Need Refrigeration by Consumers at https://www.gpo.gov/fdsys/pkg/FR-1997-02-24/html1-97-4364.htm.
- The net quantity of content declaration is not in accordance with 21 CFR 101.7(j)(1) which requires the declaration to be expressed both in ounces, with identification by weight or by liquid measure and, if applicable (1 pound or 1 pint or more) followed in parentheses by a declaration in pounds for weight units, with any remainder in terms of ounces or common or decimal fractions of the pound.
- We note that the Bulk Tofu and Sam Sung Tofu products declare different ingredient statements. Specifically, the Sam Sung Tofu product declares the ingredient water; however, the Bulk Tofu product does not declare the ingredient water. We question if the ingredient water needs to be declared in the ingredient statement for the bulk Tofu product.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done or plan to do to correct these violations and prevent their recurrence. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed.
Section 743 of the FD&C 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 FD&C Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-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 FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the U.S. Food and Drug Administration, Attention: David P. Rice, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rice by phone at 410-779-5463 or by email at email@example.com
Baltimore District Office
Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (CGMP & PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates
for CGMP & PC rule compliance dates.