Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm538642.htm
Timestamp: 2019-01-21 03:08:15
Document Index: 721482602

Matched Legal Cases: ['art 111', 'art 111', '§ 342', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 379', '§ 379']

Herbal Science International, Inc. 1/23/17
WL# 13-16
Ms. Eugenia Chang, CEO
Herbal Sciences International, Inc.
City of Industry, CA 91744-3904
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Herbal Sciences International, Inc., located at 205 Russell Street, City of Industry, CA 91744-3940 from June 7 through June 20, 2016. During the inspection of your firm, FDA identified a number of significant violations of FDA’s Current Good Manufacturing Practices (CGMP) in the Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Regulations, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These CGMP 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 the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Our investigator’s observations were presented to you on form FDA-483, Inspectional Observations, at the conclusion of the inspection on June 20, 2016. Although you stated intentions to respond to the FDA-483 in writing within 15 business days, to date no such response had been received.
1. You 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). Specifically, you have not established identity, purity, strength, and composition specifications for each of the components you use to manufacture your finished dietary supplement products.
Once you have established component specifications and before using a component, you must, among other requirements, comply with 21 CFR 111.75 and 111.95.
2. You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that 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(e). Specifically, you have not established finished product specifications.
Once you have established finished product specifications, you must, among other requirements, determine whether the specifications have been met as required by 21 CFR 111.75(c), and you must make and keep records for established specifications, as required by 21 CFR 111.95(b)(1).
3. You 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. Specifically, you did not have any written procedures for quality control operations for the dietary supplements you distribute.
Once you have established the required quality control written procedures, you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (MMR), as required by 21 CFR 111.65.
4. You failed to prepare and follow 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). Specifically, you did not prepare and follow MMRs for the following batches of finished dietary supplements manufactured by your firm:
Xiao Ke Wan (Diabetic Formula) (b)(4)
Ping Ya San (Pressure Reduce Formula) (b)(4)
B041610
Ruan Jian Xiao Zhen Tang (Tumor, Cancer Fighter #1, 10:1) (b)(4)
J20145B
She Hu Xiao Zhong Wan (Prostate Ease) (b)(4)
C311504
An He Jian Fei Wan (An Ho Diet Pills) (b)(4)
E151503
Geng Nian Fu Bao Wan (New Spring Menopause Formula) (b)(4)
Quiang Jing By Shen Wan (Kidney Essence Power) (b)(4)
For each unique formulation of a dietary supplement you manufacture, you must prepare and follow an MMR that includes the information specified in 21 CFR 111.210.
5. You failed to prepare batch production records (BPRs) that include complete information relating to the production and control of each batch and failed to include all information required in a BPR, as required by 21 CFR 111.255(b) and 111.260.
Specifically, your BPRs did not include the following required information:
The identity of equipment and processing lines used in producing the batch, as required by 21 CFR 111.260(b);
The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or cross references to such records, such as individual equipment logs, where this information is retained, as required by 21 CFR 111.260(c);
A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing, as required by 21 CFR 111.260(f);Documentation, at the time of performance, of the manufacture of the batch, including the initials of the person performing each step, including:
o The initials of the person responsible for weighing or measuring each component used in the batch, as required by 21 CFR 111.260(j)(2)(i);
o The initials of the person responsible for verifying the weight or measure of each component used in the batch, as required by 21 CFR 111.260(j)(2)(ii);
Documentation, at the time of performance, of packaging and labeling operations, including;
o The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels, as required by 21 CFR 111.260(k)(1);
o An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR, as required by 21 CFR 111.260(k)(2);
Documentation, at the time of performance, that quality personnel reviewed the BPR, including:
o Review of any monitoring operation required under 21 CFR 111 subpart E, Requirement to Establish a Production and Process Control System, as required by 21 CFR 111.260(l)(1)(i);
o Approval and release of, or rejection of, the batch for distribution, including any reprocessed batch, as required by 21 CFR 111.260(l)(3); and
o Approval and release of, or rejection of, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement, as required by 21 CFR 111.260(l)(4).
6. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distributing dietary supplement products, including, but not limited to, the requirements under 21 CFR 111.455 and 111.465.
7. You failed to establish and follow written procedures to fulfill the requirements for returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have not established written procedures for returned dietary supplements.
8. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you did not have written procedures for reviewing and investigating product complaints (see 21 CFR 111.560).
9. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you do not collect and hold reserve samples.
10. You failed to establish and follow written procedures for fulfilling the requirements for equipment and utensils, including written procedures for calibrating instruments and controls that you use in manufacturing your dietary supplement, as required by 21 CFR 111.25(a). Additionally, you failed to calibrate instruments and controls you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.27(b). Specifically, you have not established and followed written procedures for calibrating instruments used in manufacturing your dietary supplements, and you have never calibrated the weighing scale (b)(4) used to weigh components.
1. Your She Hu Xioao Zhong Wan, Ruan Jian Xio Zheng Tang, Qiang Jing Bu Shen Wan, Ping Ya San, New Spring Menopause Formula, and An Ho Diet Pills 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 presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36.
2. Your Ruan Jian Xiao Zheng Tang, Qiang Jing Bu Shen Wan, Ping Ya San, New Spring Menopause Formula, and An Ho Diet Pills products are misbranded within the meaning of section 403(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) Table 2.
3. Your She Hu Xioao Zhong Wan, Ruan Jian Xio Zheng Tang, Qiang Jing Bu Shen Wan, Ping Ya San, New Spring Menopause Formula, and An Ho Diet Pills products are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] in that the labels fail to list the servings per container under the serving size on the left hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR 101.36(b)(1)(ii).
4. Your Ruan Jiam Xiao Zeng Tang, Qiang Jing Bu Shen Wan, and Ping Ya San 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).
5. Your She Hu Xioao Zhong Wan, Ruan Jian Xio Zheng Tang, Qiang Jing Bu Shen Wan, Ping Ya San, New Spring Menopause Formula, and An Ho Diet Pills products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because each label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
6. Your She Hu Xioao Zhong Wan, Ruan Jian Xio Zheng Tang, Qiang Jing Bu Shen Wan, Ping Ya San, New Spring Menopause Formula, and An Ho Diet Pills products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343 (f)] because the product labels contain information in two languages but do not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
7. Your She Hu Xioao Zhong Wan, Ruan Jian Xio Zheng Tang, Qiang Jing Bu Shen Wan, Ping Ya San, New Spring Menopause Formula, and An Ho Diet Pills products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343 (y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these products do not include complete addresses or phone numbers.
You should take prompt action to correct and prevent the reoccurrence of the violations specified above as well as the other violations outlined on Form FDA 483, List of Inspectional Observations, issued at the close of the inspection. Failure to do so may result in an enforcement action by FDA without further notice, including, without limitation, seizure and injunction.
Within 15 working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.
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 about this letter, please contact Daniel W. Cline, Compliance Officer, at 949-608-4433, or via e-mail to Daniel.Cline@fda.hhs.gov.