The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility, Chi’s Enterprise, Inc., located at 1435 North Brasher St., Anaheim, CA 92807on 9/20-21/2017 and 10/4/2017. 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 the dietary supplement products you distribute 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.
We did not receive a written response with any evidence documenting corrections to observations noted on the Form FDA 483, Inspectional Observations, which we issued to you on 10/4/2017. At the time we write this letter we are unable to assess if you have implemented any of the corrections you promised during the inspection.
The significant violations documented during the inspection include, but are not limited to, the following:
1. 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. During the inspection, you informed our investigator that your firm has dietary supplements manufactured by a contract manufacturer using ingredients that you provide and that your contract manufacturer then ships to your facility the bulk finished dietary supplements capsules for you to perform further packaging and labeling operations. However, your written procedures for the responsibilities of quality control operations do not include procedures for:
Approving for release, or rejecting, any packaged and labeled dietary supplement for distribution (21 CFR 111.127(h)); and
Conducting a material review and making a disposition decision, such as reviewing documentation from the manufacturers with whom you contract relating to how the products you release into commerce are manufactured and whether they conform to established specifications (21 CFR 111.127(e)).
Once you have established the required quality control procedures, you must make and keep written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision (21 CFR 111.140(b)(1)).
You failed to establish the required specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a).
Your firm imports and receives dietary ingredients which you then ship to your contract manufacturer, (b)(4). Your contract manufacturer (b)(4) which the contract manufacturer packages and ships to your firm in bulk. Your firm then re‐packages the bulk supplements into retail sized bottles and labels this finished product under the Chi brand name. Your firm develops your various products, selects suppliers, and works directly with your ingredient manufacturers.
During the inspection, we collected records for your Myomin 500 mg capsules, batch number CHI16006MN. The records provide instructions for the use of the ingredients you provide in the manufacture of the finished dietary supplements, including instructions relating to the type of capsules to be used, size of the capsules to be used, fill weight of ingredients in the capsule, the specific filler to be used such as “(b)(4), and an estimated capsule count. These records fail to satisfy the following requirements for specifications:
You failed to establish component specifications for each component used in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Specifically, you did not establish the following specifications for components, such as [B4] Extract, [B4] Extract, and Astragalus Extract:
o Identity specifications (21 CFR 111.70(b)(1)).
o Component specifications that are necessary to ensure that the specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met (21 CFR 111.70(b)(2)).
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 (21 CFR 111.70(b)(3)).
You failed to establish specifications for dietary supplement labels (label specifications), as required by 21 CFR 111.70(d).
You failed to establish specifications to provide sufficient assurance that the product you receive from your contract manufacturer for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f).
You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g).
3. You failed to identify each unique lot within each unique shipment of components that you received in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component, and to the dietary supplement that you distributed, as required by 21 CFR 111.155(d)(1). Specifically, your receiving records (“Master Record Log” and “Detailed Shipment Log”) do not contain information for each individual lot of dietary ingredient received. For example, we reviewed your “Detailed Shipment Log” dated 07/15/2016 that identifies (b)(4) drums of Myomin, batch CHI16006MN (a finished product), incoming from (b)(4). The warehouse manager explained this record is for the receiving of Astragalus extract, batch (b)(4), and Curcuma extract, batch (b)(4), which shipped from (b)(4) on 06/22/2016, and Cyperus Extract, batch (b)(4), which shipped from (b)(4) on 12/28/2015. The record does not include the receiving date for each ingredient, the name of each ingredient, supplier information, the ingredient status, or any other information that would allow for material traceability such as a batch number, lot number, or manufacture date.
4. Your batch production record (BPR) failed to include complete information relating to the production and control of each batch and did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, you repackage and label for distribution the bulk dietary supplements, Myomin Capsules, that you receive from your contract manufacturer. Your batch production records (“Repacking Logs”) do not include required elements including (but not limited to):
The identity of the equipment used in producing the batch (21 CFR 111.260(b));
The unique identifier assigned to each product that you receive from a supplier for packaging and labeling as a dietary supplement, and the unique identifier of each packaging and label used (21 CFR 111.260(d));
Documentation, at the time of performance, of packaging and labeling operations, including:
o The quantity of the packaging and labels used (21 CFR 111.260(k)(1));
o An actual or representative label, or cross reference to the physical location of the actual or representative label specified in the master manufacturing record (21 CFR 111.260(k)(2));
o The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross reference to the physical location of such results (21 CFR 111.260(k)(3));
Documentation at the time of performance of any reprocessing (21 CFR 111.260(n);
Documentation at the time of performance that quality control personnel reviewed the BPR, including:
o Review of any monitoring operations (21 CFR 111.260(l)(1)(i));
o Review of the results of any tests and examinations on components, finished batches of dietary supplement, and packaged and labeled dietary supplements (21 CFR 111.260(l)(1)(ii));
Documentation at the time of performance that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement (21 CFR 111.260(l)(4)).
5. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, your written procedure SOP CHI.2012.12, “Consumer Complaints,” does not include requirements related to the review and investigation of a product complaint (21 CFR 111.560). The RMA log dated 01/10/2017 through 07/24/2017 includes four product complaints (RMAs 2442, 2449, 2433, and 2421); however, your firm does not have product complaint records for these incidents to show that a complaint review was performed and whether an investigation was required or conducted. Furthermore, section four of this SOP, Product Specifications, states that a product complaint must be verified; however, it does not state what is meant by verified or include steps on how to perform such a verification. Once you have established and followed procedures to fulfill the requirements related to product complaints, you must make and keep records related to the product complaints, as required by 21 CFR 111.570.
6. You failed to make and keep records for returned dietary supplements, as required by 21 CFR 111.535. Specifically, you have no records of the material review and disposition decision for 20 returned dietary supplements.
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 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/or injunction.