BioLyte Laboratories, LLC — FDA Warning Letter Findings

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)). You did not perform at least one specific identity test for each component used in production of your OTC and Homeopathic drug products. During the inspection, you stated that you do not perform identity…

Your (b)(4) Silver and (b)(4) Silver (b)(4) products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Additionally, 1. Your (b)(4) Silver Liquid Supplement, (b)(4) Silver, (b)(4) Silver (b)(4) , and (b)(4) Silver product labels bear the following statement: “DV (Daily Value) based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, added sugars, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).

Your (b)(4) Silver and (b)(4) Silver Water products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. 343 (e)(1)] in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

Your (b)(4) Silver Liquid Supplement, (b)(4) Silver, (b)(4) Silver (b)(4) , and (b)(4) Silver 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 products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. For example: Your (b)(4) Silver Liquid Supplement, (b)(4) Silver, (b)(4) Silver (b)(4) , and (b)(4) Silver products labels fail to list the serving sizes which include 1 teaspoon twice daily for people under 75 pounds (lbs.) and 2 teaspoons twice daily for people over 75 lbs. If the product is for persons within more than one group, the quantitative amount and percent of Daily Value for each group shall be presented in separate columns in accordance with 21 CFR 101.36(b)(2)(iii)(E)…

Your (b)(4) Silver, (b)(4) Silver (b)(4) , and (b)(4) Silver products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] because the product labels do not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).

Your firm failed to establish a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). You do not have appropriate stability data to support the 3-year expiration date for the OTC Pain Relief drug product that you manufacture. During the inspection, you provided evidence that you perform a visual, odor, and pH…

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). You released your over-the-counter (OTC) topical drug products without adequate quality control testing, including but not limited to the identity and strength of each active ingredient. For example, identity…

Your (b)(4) Silver Liquid Supplement, (b)(4) Silver, (b)(4) Silver (b)(4) , and (b)(4) Silver product labels are using an incorrect version of the FDA disclaimer. This FDA disclaimer is only required when certain statements as mentioned in 21 CFR 101.93(f) are declared on the label. CGMP consultant recommended Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. We also recommend that the qualified third party perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the effectiveness of your corrective actions and preventive actions. Your use of a consultant does not relieve your firm's obligation to comply with CGMP. Your firm's executive management remains responsible for fully resolving all deficienci…