Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm419752.htm
Timestamp: 2019-04-21 14:51:53+00:00

Document:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 620 Queen Avenue SW, Albany, Oregon, from March 10, 2014, through April 2, 2014. During the inspection, we evaluated your dietary supplement manufacturing, packaging, labeling, and holding operations, consistent with Title 21, Code of Federal Regulations (21 CFR) Part 111. Our investigators identified significant violations of the dietary supplement Current Good Manufacturing Practice (CGMP) regulations found in 21 CFR Part 111. These violations cause your dietary supplement products CORYDALIS and CVF BGONE 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 the CGMP regulations for dietary supplements.
Additionally, during the inspection our investigators collected for our review the labels associated with many of your products. In October 2014, FDA also reviewed your website at the Internet address www.betterhealthherbs.com. Based on this review, we determined that you take orders on your website for Parasite Cleanse Kit (Product 4474), STRP-THRT (Product 1402), STMCH ULCRS (Product 1396), ULCRS (Product 1438), Depression Gone EFR (Product 6312), CGHS & SRE THRT SYRP (Product 1087), Allergy Relief Kit (Product 1012), ADD & ADHD Focus EFR (Product 6302), and Fibromyalgia Kit Plus (Product 4440), which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
We received your response, dated April 16, 2014, concerning the observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations.
2. You also have disease claims within product names found on your website at www.betterhealthherbs.com. Some examples of these names include: STRP-THRT (Product 1402), STMCH ULCRS (Product 1396), ULCRS (Product 1438), Depression Gone EFR (Product 6312), CGHS & SRE THRT SYRP (Product 1087), Allergy Relief Kit (Product 1012), ADD & ADHD Focus EFR (Product 6302), and Fibromyalgia Kit Plus (Product 4440).
Your products identified above are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your Parasite Cleanse Kit, STRP-THRT, STMCH ULCRS, ULCRS, ADD & ADHD Focus EFR, and Fibromyalgia Kit Plus products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended uses. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
1. You failed to establish a written master manufacturing record (MMR) for your dietary supplement products, as required by 21 CFR 111.205. Specifically, your firm has not prepared a written 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).
We received your response dated April 16, 2014. We acknowledge that in your response you stated that your firm had already “[p]repared a master manufacturing record for each batch of dietary supplement manufactured.” However, you did not provide any supporting documentation of your corrective actions, such as a copy of your MMRs.
2. You failed to prepare a batch production record every time you manufacture a batch of dietary supplements, as required by 21 CFR 111.255(a). Specifically, you do not have batch production records for your CORYDALIS and CVF BGONE products.
We received your response dated April 16, 2014. We acknowledge that in your response you stated that your firm has already begun preparing batch production records and specifications for every batch manufactured. However, you did not provide any supporting documentation of your corrective actions, such as a copy of a batch production record for your dietary supplements.
3. Your firm failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of dietary supplements to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.55. Specifically, your firm does not have an established system of production and process controls for any stages of the manufacturing, packaging, labeling, and holding of your CORYDALIS and CVF BGONE.
We received your response dated April 16, 2014. We acknowledge that in your response you stated that your firm completed your correction on April 11, 2014. You also stated in your response that you were attaching evidence of your corrective action. However, no such evidence was attached. Your response is inadequate because you do not provide evidence that a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of your dietary supplements has been implemented.
a. Identity specifications, as required by 21 CFR 111.70(b)(1).
b. Component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2).
c. Establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3).
We received your response dated April 16, 2014. We acknowledge that in your response you stated that your firm has already begun establishing identity specifications for purity, strength, and composition for all components used in the manufacturing of dietary supplements. However, you did not provide any supporting documentation of your corrective actions such as a copy of such specifications for a component used in the manufacturing of dietary supplements.
5. Your firm did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i), nor has the FDA received a petition from you, and granted the petition, to exempt you from this testing requirement, pursuant to 21 CFR 111.75(a)(1)(ii). Specifically, you have not conducted identity testing to verify the identity of any components that are dietary ingredients, prior to their use in the manufacturing of your CORYDALIS and CVF BGONE, nor has FDA received from you and granted a petition exempting you from such testing requirement.
We received your response dated April 16, 2014. We acknowledge that in your response you stated that your firm will complete this correction by June 15, 2014. Your response is inadequate because you did not provide evidence that testing or examination procedures have been implemented or what procedures will be implemented to verify the identity of your dietary ingredients prior to use.
a. Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a).
b. Calibrating, inspecting, and checking automated, mechanical, and electronic equipment, as required by 21 CFR 111.25(b).
c. Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.25(c).
Specifically, our investigator determined that you lack written procedures for calibrating scales, pH meters, and other equipment used in the manufacturing of your CORYDALIS and CVF BGONE products.
We received your response dated April 16, 2014. We acknowledge that in your response you stated that your firm completed your correction on April 15, 2014. Your response is inadequate because you did not provide any supporting documentation of your corrective actions, such as a copy of the Equipment Maintenance Procedure you state that you have established or evidence of any equipment maintenance records that have been created to date.
7. You failed to hold reserve samples of each lot of packaged and labeled dietary supplement that you distribute, as required by 21 CFR 111.83(a). During the inspection you confirmed to our investigator that you do not hold reserve samples of your CORYDALIS and CVF BGONE.
We received your response dated April 16, 2014. We acknowledge that in your response you stated that your firm completed your correction on April 15, 2014. Your response is inadequate because you did not provide any supporting documentation of your corrective actions, such as a copy of the site procedure for collection and holding of reserve samples, and a list of reserve samples collected since the close of your last inspection dated April 2, 2014.
1. Your CORYDALIS and CVF BGONE products are misbranded within the meaning of sections 403(s)(2)(A)(ii)(I) and 403(q)(5)(F) of the Act [21 U.S.C. § 343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the label fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36.
2. Your CORYDALIS and CVF BGONE products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
Your CVF BGONE label fails to include the part of the plant from which Wormwood, Scullcap Herb, Lobelia Herb, and Hydrangea are derived.
Your CORYDALIS label fails to include the part of the plant from which CORYDALIS is derived.
4. Your CORYDALIS product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
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.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps 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 corrective action.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Jessica Kocian, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Kocian at 425-302-0444 or at the above address.

References: § 342
 § 321
 § 321
 § 355
 § 331
 § 352
 § 331
 § 343
 § 343
 § 343
 § 379
 § 379