FDA Warning Letter to Genesis Herb Company LLC

VIA United Parcel Service

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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. In addition, you have not identified personnel to be responsible for your quality control operations as required by 21 CFR 111.12(b). Specifically, you failed to identify any employee(s) who are responsible for your quality control operations.

During the inspection, you told our investigator that you were working on creating the necessary written procedures for compliance. However, you did not submit a written response to the FDA-483 or provide any supporting documentation of your corrective actions.

2.  You failed to prepare and follow a written master manufacturing record 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 were unable to provide written master manufacturing records for any of the dietary supplements that you manufacture, including your Seizure, Relax, Formula ARTH, Disintegrate, Gout, and Plantain dietary supplement products. Please note that a master manufacturing record for each unique formulation of a dietary supplement must include the elements specified in 21 CFR 111.210. 

3.  You failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of 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, as required by 21 CFR 111.55. In addition to failing to prepare and follow written master manufacturing records, as discussed above, you failed to establish specifications, as required by 21 CFR 111.70.  For example, you failed to establish a specification 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 [21 CFR 111.70(a)]. Additionally, you failed to establish specifications for each component that you use in the manufacture of a dietary supplement, including identity specifications and specifications that are necessary to ensure the purity, strength and composition of dietary supplements manufactured using the components, as required by 21 CFR 111.70(b)(l) and (2). Further, you failed to 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). Specifically, you use components, such as distilled water, Milk Thistle, Plantain,  Knitbone, and powered herbs, in the manufacture of your Seizure, Relax, Formula ARTH, Disintegrate, Gout, and Plantain dietary supplement products and you have failed to establish any specifications for these components.  Furthermore, you have not established finished product specifications, as required by 21 CFR 111.70(e) or in-process specifications, as required by 21 CFR 111.70(c).  

We would like to remind you that manufacturers generally are responsible for more than just establishing specifications. Once you have established the specifications required under 21 CFR 111.70, you must determine whether these specifications are met [21 CFR 111.73]. 21 CFR 111.75 sets forth the requirements for determining whether specifications are met, including testing the finished batch of dietary supplement in accordance with the requirements of 21 CFR 111.75(c).

4.  You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453.  Specifically, you did not provide documentation of written procedures for holding and distributing operations. Additionally, you are required to make and keep records for your holding and distribution operations, as required by 21 CFR 111.475(a). 

5.  Your batch production records failed to include complete information relating to the production and control of each batch and the information required to be included in a batch record, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your firm uses a formula mix sheet when preparing the dry herbal pre-mix used to manufacture each batch of your liquid dietary supplement products. While the formula mix sheet lists the ingredients of the dry herb blend, the manufacturer of each herb, the lot number of each dry herb, and the lot number assigned to each batch of finished liquid dietary supplements, it does not contain the following required elements:

• The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
• The date and time of the maintenance, cleaning, and sanitizing of the equipment used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)];
• The weight or measure of each component used [21 CFR 111.260(e)];
• A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)];
• The actual results obtained during any monitoring operation [21 CFR 111.260(g)];
• The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)];
• Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)];
• Documentation, at the time of performance, of the manufacture of the batch [21 CFR 111.260(j)];
• Documentation, at the time of performance, of packaging and labeling operations [21 CFR 111.260(k)];
• Documentation at the time of performance that quality control personnel perform required functions [21 CFR 111.260(l)];
• Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)];
• Documentation at the time of performance of any reprocessing [21 CFR 111.260(n)].

This page was posted on January 24, 2019.