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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Finemost Corporation 3/20/13

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506
Telephone:    949-608-2900
FAX:    949-608-4417 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE                                                         
SIGNATURE REQUIRED
 
March 20, 2013
WL# 32-13
Mr. Samuel C.S. Chang, CEO                                                                                               
Finemost Corporation dba Qualiherb
13839 Bentley Place
Cerritos, CA 90703-2433
 
Dear Mr. Chang:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Finemost Corporation dba Qualiherb, located at 13839 Bentley Place, Cerritos, CA 90703-2433 from September 12 through September 21, 2012. The inspection revealed violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation for dietary supplements. (21 CFR Part 111). 
 
These CGMP violations cause your (b)(4) and (b)(4) products to be adulterated within the meaning of section 402(g)(1) of 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 our inspection on September 21, 2012.
 
Your Yi Zhi Tang and C. Aquino’s Happy Pregnancy for Vadevali, Eva Vives products are also in violation of section 403 of the Act [21 U.S.C. § 343] and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. 
 
Dietary Supplement CGMP Violations
 
The inspection revealed the following violations of FDA’s CGMP regulations:
 
1. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, your firm contract manufactures the dietary supplement (b)(4). Your firm did not perform any test or examination to verify the identity of (b)(4) (Lot# (b)(4)), (b)(4) (Lot# (b)(4)) or (b)(4) (Lot# (b)(4)), which were used in the manufacture of (b)(4) Lot# (b)(4). Your firm also contract manufactures the dietary supplement (b)(4). Your firm did not perform any test or examination to verify the identity of (b)(4) or (b)(4), which were used in the manufacture of (b)(4), Lot# (b)(4).
 
We acknowledge that your firm’s response states that you have requested testing on three dietary ingredients used to manufacture (b)(4) Lot# (b)(4). Additionally your firm’s response includes a document titled “Incoming Shipment Stocking Procedure” dated 9/24/2012. That document requires “periodic” sample tests to be performed to verify the incoming components. Your response, however, is inadequate. The testing you describe does not satisfy the requirement in 21 CFR 111.75(a)(1)(i) that your firm conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use.  The requirement to verify the identity of any component that is a dietary ingredient applies unless you petition FDA under section 21 CFR 111.75(a)(1)(ii) and FDA exempts you from such testing.
 
2. Your firm has not established component specifications for each component that you use in the manufacture of a dietary supplement that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements you manufacture using those components are met, as required by 21 CFR 111.70(b)(2). Specifically, our investigator observed that you have not established specifications for the components used in your manufacturing process.  
 
3. Your firm has failed to determine whether components meet established specifications for purity, strength, and composition, as required by 21 CFR 111.75(a)(2). Specifically, you receive Certificates of Analysis (COA) for components from your supplier, (b)(4); however, you do not review the COAs, nor have you qualified this supplier. Under 21 CFR 111.75(a)(2), a certificate of analysis may be relied upon to confirm whether applicable component specifications established in accordance with 21 CFR 111.70(b) are met. In order to rely on a certificate of analysis from a supplier of the component, the following requirements of 21 CFR 111.75(a)(2)(ii) must be met: (A) qualify the supplier by establishing the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s tests or examinations; (B) the certificate of analysis must include a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (C) maintain documentation of how the supplier was qualified; (D) periodically re-confirm the supplier’s certificate of analysis; and (E) the documentation setting forth the basis for qualification (and re-qualification) of any supplier must be reviewed and approved by quality control personnel.
 
4. Your firm failed to monitor the in-process points, steps, or stages where control is necessary to ensure the quality of the finished batch of dietary supplement to determine whether the in-process specifications are met, as required by 21 CFR 111.75(b)(1). Specifically, your firm does not conduct in-process testing of the weight of individual capsules during contract manufacturing operations for the dietary supplement (b)(4), which is labeled as containing 600 mg per capsule. Prior to receiving the capsules for packaging into bottles, it is your firm’s practice to measure the total weight of 100 capsules, divide that weight by 100, and then record the resulting value in milligrams. This practice does not ensure that finished batches of dietary supplement meet in-process specifications for weight per capsule.
 
5. Your firm’s master manufacturing records (MMRs) fail to include the following information required by 21 CFR 111.210:
 
  • Your MMRs failed to include the identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label. [21 CFR 111.210(d)]
  • Your MMRs failed to include a statement of any intentional overage amount of a dietary ingredient. [21 CFR 111.210(e)]
  • Your MMRs failed to include a statement of theoretical or expected yields. [21 CFR 111.210(f)]
  • Your MMRs failed to include a description of packaging. [21 CFR 111.210(g)]
  • Your MMRs failed to include written instructions of specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. [21 CFR 111.210(h)(1)] Specifically, your MMRs failed to include instructions of such specifications as blending time, blending speed and filling of capsules.
  • Your MMRs failed to include written instructions for corrective action plans for use when a specification is not met. [21 CFR 111.210(h)(5)]
 
Although we acknowledge that your firm’s response included two documents entitled “Manufacturing Working Sheets” and “Manufacturing Procedure,” your response was inadequate. Your firm’s response did not include all of the information required by 21 CFR 111.210.
 
6. Your firm’s batch production records (BPR) did not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). Specifically, your BPRs did not include the following required information:
 
  • Your BPRs failed to include the identity of the equipment used in producing the batch. [21 CFR 111.260(b)]
  • Your BPRs failed to include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records where this information is retained. [21 CFR 111.260(c)]
  • Your BPRs failed to include the unique identifier that your firm assigned to gelatin capsules, packaging and label. [21 CFR 111.260(d)]
  • Your BPRs fails to include a statement of actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing. [21 CFR 111.260(f)]
  • Your BPRs failed to include documentation, at the time of performance, of packaging and labeling operations. [21 CFR 111.260(k)]
  • Your BPRs failed to include documentation at the time of performance that quality control personnel reviewed the batch production record. [21 CFR 111.260(l)]
  • Your BPRs failed to include documentation at the time of performance that quality control personnel approved and released, or rejected, the batch for distribution. [21 CFR 111.260(l)(3)]
 
7.   Your firm’s quality control operations for your BPR failed to approve and release, or reject, each finished batch for distribution, as required by 21 CFR 111.123(a)(8). Specifically, your firm’s quality control operations do not involve conducting a review and approval of BPRs prior to the release of each finished batch of your dietary supplements for distribution.
 
8. Your firm failed to establish and follow written procedures for quality control operations, as required by 21 CFR 111.103. Specifically, your firm does not have written procedures for the following required quality control operations:
 
  • Approving or rejecting specifications that may affect the identity, purity, strength or composition of a dietary supplement [21 CFR 111.105(a)]
  • Ensuring that representative samples are collected [21 CFR 111.105(f)]
  • Ensuring that reserve samples are collected [21 CFR 111.105(g)]
 
We acknowledge that your firm’s response addressed quality control procedures involving receiving components, packaging and labeling, establishing master manufacturing records and disposition of quarantined products. Your response was nevertheless inadequate in that it did not address all the quality control procedures necessary to ensure the quality of the dietary supplements your firm contract manufactures.
 
Misbranded Dietary Supplements 
 
1.    Your Yi Zhi Tang and C. Aquino’s Happy Pregnancy for Vadevali, Eva Vives 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 number of servings per container is not declared [21 CFR 101.36(b)(1)(ii)].
 
2.    Your Yi Zhi Tang and C. Aquino’s Happy Pregnancy for Vadevali, Eva Vives 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 “Supplement Facts” panel is not in an appropriate format as defined in 21 CFR 101.36. The title “Formula Facts” should be changed to “Supplement Facts” [21 CFR 101.36(e)(1)].
 
3.    Your Yi Zhi Tang and C. Aquino’s Happy Pregnancy for Vadevali, Eva Vives products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. 343(s)(2)(C)] in that the products contains extracts derived from botanical ingredients but do not identify the part of the plant from which these dietary ingredients are derived, in accordance with 21 CFR 101.4(h)(1).
 
4.    Your Yi Zhi Tang and C. Aquino’s Happy Pregnancy for Vadevali, Eva Vives products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that they fail to list the common or usual name of ingredients of dietary supplements that are botanicals consistent with the names standardized in Herbs of Commerce, 1992 edition, in accordance with 21 CFR 101.4. For example, the standardized common name for the dietary ingredient Da Huang, listed on your Yi Zhi Tang label is Chinese rhubarb. Similarly, the standardized common name for the dietary ingredient, Fu Shen, listed on your C. Aquino’s Happy Pregnancy for Vadevali Eva Vives label is Poria.
 
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.
                                                                                                                                                                
You should take prompt action to correct the violations specified above and prevent their reoccurrence. Failure to do so may result in regulatory action by FDA without further notice, including seizure and/or injunction. 
 
Within fifteen (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 and to ensure that similar violations do not occur. Include in your response any documentation necessary to show that corrections have 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. Refer to the Unique Identification Number (CMS Case: 369218) when replying. 
 
Please send your written response to this letter to:
 
Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA   92612
 
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 Jennifer M. Gogley, Acting Compliance Officer, at 949-608-3523.
 
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
 
cc:       
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Avenue, MS-7602
Sacramento, CA   95899-7413
Attn: FDA Correspondence