US FDA Validation and qualification findings

Specifically, your antiperspirant products are labeled to contain aluminum chlorohydrate 10%, and aluminum chloride 10%, as active ingredients. While each active ingredient is individually permitted by M019.10, these active ingredients are not permitted when used in this combination (or any other combination) in a single antiperspirant drug product. Thus, your syNeo antiperspirant products do not comply with the applicable conditions specified in M019 and have not otherwise been found GRASE. 3 Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without an approved application. Because there are no applications in effect for these products, these products are unapproved new drugs. The introduction or delivery for introduction of these unapproved new drug products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Misbranded Drug Violations Additionally, your syNeo antiperspirant products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355. The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Consultant Based on the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. Quality Systems Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download; Q9(R1) Quality Risk Management at https://www.fda.gov/media/167721/download; and Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download.

Employee training and qualification is inadequate.

Deficiencies in shipping validation.

Validation of analytical methods is incomplete.

During the validation of insulin aspart in human serum (validation report #1000-2403020), the effect of lipemia for selectivity and matrix effect experiments was not evaluated.

Source records for method validation experiments of long-term stability (validation report #1000-091480-2), dilution integrity, stability in matrix and ion suppression (validation report #1000-091480-1), do not document that lithium heparinized human lysed whole blood was utilized as the matrix.