Inspections, Compliance, Enforcement, and Criminal Investigations

S.S.O., Inc dba BYS Company 9/23/16

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900                                   
FAX: 949-608-4415 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
September 23, 2016                                                                                       
WL # 49-16
Mr. James W. Sims, President and Owner
SSO, Inc. dba BYS Company
18273 Grand Ave. #5&8
Lake Elsinore, CA 92530-6118
 
Dear Mr. Sims:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, S.S.O., Inc. dba BYS Company, (b)(4) , from February 19 through March 18, 2016. The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet cGMP requirements for dietary supplements. 
 
Additionally, we reviewed the labeling of your dietary supplement products collected during the inspection of your facility. Based on our review, your (b)(4) and  (b)(4) dietary supplements fail to comply with FDA’s labeling regulations under 21 CFR Part 101 and are misbranded under section 403 of the Act [21 U.S.C. § 343]. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
 
We have received your written response, dated April 5, 2016, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on March 18, 2016. Your response does not address any of the violations found at your facility; as a result, we are unable to evaluate the adequacy of any corrective actions you may have taken.  
 
Adulterated Dietary Supplements
 
During the inspection, investigators observed the following significant violations:
 
1.    Your firm failed to prepare and follow a written master manufacturing record (MMR), for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, you have not prepared and followed a written MMR for your (b)(4) in 1-ounce and 2-ounce bottles and (b)(4) in 4-ounce bottles.
 
2.    Your firm failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70. Specifically, you have not established a specification for the (b)(4) used in the manufacture of your dietary supplement products. Your firm further failed to establish specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). For example, you do not have specifications for water, which you use as a component in your dietary supplement products.
 
Once you have established the above specifications, you must determine whether the specifications have been met, as required by 21 CFR 111.73. We also note that you must make and keep records for the established specifications, as required by 21 CFR 111.95(b)(1).
 
3.    You failed to ensure that water used in a manner such that the water may become a component of the dietary supplement complies, at a minimum, with applicable Federal, State, and local requirements, and that the water does not contaminate the dietary supplement, as required by 21 CFR 111.15(e)(2). Water is used as a component in your dietary supplements, but you do not conduct testing to show that your purification equipment is suitable for use and can produce potable water consistently. 

Once you have ensured that your testing meets the requirements of 21 CFR 111.15(e)(2), you must make and keep records that show that water, when used in a manner such that the water may become a component of the dietary supplement, meets the requirements of 21 CFR 111.15(e)(2), as required by 21 CFR 111.23(c).
 
4.    Your firm failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103, and to make and keep such written procedures, as required by 21 CFR 111.140(b)(l). Specifically, you did not have any written procedures for quality control operations for the dietary supplements you manufacture and distribute.
 
Once you have established your quality control written procedures, you must implement all required quality control operations in your manufacturing, packaging, labeling, and holding operations, as required by 21 CFR 111.65.
 
Misbranded Dietary Supplements
 
Our review of the labeling of your dietary supplement products collected during the inspection of your facility revealed the following significant violations:
 
1.    Your (b)(4) and (b)(4) dietary supplement products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the labels failed to comply with 21 CFR 101.36 as follows:
  • The dietary ingredients in your (b)(4) and (b)(4) proprietary blends are not indented under the term “Proprietary Blend as required by 21 CFR 101.36(c)(2);
  • You list the dietary ingredients “major and trace minerals,” “ amino acids,” “enzymes,” on your (b)(4) and (b)(4) product labels, but you failed to list the individual major and trace minerals, amino acids, and enzymes within the “Supplement Facts” panels, as required by 21 CFR 101.36(b)(2) and (b)(3);
  • The product labels for (b)(4) and (b)(4) list ingredients such as "Pure Water" and "Dissolved Oxygen" inside the Supplement Facts panel. Under 21 CFR 101.4(g), these ingredients must be listed immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label. These ingredients must be preceded by the word "Ingredients," unless some ingredients (i.e., sources) are identified within the nutrition label in accordance with 21 CFR 101.36(d);
2.    Your (b)(4) and (b)(4) products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b).
 
a.    Your (b)(4) Directions state to “take 5 to 10 drops in 12 – 20 fl. oz. or more of… up to 15 per dose…” but the serving size states 5 drops.
b.    Your (b)(4) Directions state to “take 15 drops in 16 ounces or more…” but the serving size states 30 drops.
 
This letter is not intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that your establishment and your products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and injunction.
 
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
 
If you have any questions concerning this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at 949.608.2918, or via e-mail to raymond.brullo@fda.hhs.gov.
 
Please send your written response to this letter to:
 
Kelly Sheppard
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA   92612
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Los Angeles District Director
 
 
cc:       
David M. Mazzera, PhD,
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435

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