Mericon Industries, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your Florical 100 Capsules, Florical 500 Capsules, and Meribin 120 Capsules, dietary supplement 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 products does not comply with 21 CFR 101.36 and 21 CFR 101.9, and 21 CFR 101.4. For example, the calculated % Daily Value for all (b)(2)-dietary ingredients must be the quantitative amount by weight per serving divided by the RDI for each respective nutrient established in 21 CFR 101.9(c)(8)(iv), and expressed to the nearest whole percent in accordance with 21 CFR 101.36(b)(2)(C).

Passage 2

Your batch production records failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your batch production records for the Florical and Meribin dietary supplement products that you manufacture failed to include: - The identity of the equipment and processing lines used in producing the batch (21 CFR 111.260(b)); - 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 that quality control personnel reviewed the batch production record (21 CFR 111.260(l)(1)).

Passage 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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, during the inspection, when our investigator requested your written procedures for quality control operations, you were not able to provide any written procedures for quality control operations that are used to ensure the quality of the dietary supplements.

Passage 4

You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants 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 identity specifications for your finished Florical and Meribin products. The identification test described in your batch records for these products are not adequate because they only include visual examination. Visual examination of the encapsulated powder is not be an appropriate identity test due to decreased reliability in confirming the identity of the product, potentially resulting in misidentification.