Strukmyer LLC dba Strukmyer Medical

Your quality unit (QU) failed to ensure the chemical and microbial testing methods performed by your contract laboratory for finished drug product release testing and water system monitoring were not adequately validated or verified as appropriate.

You failed to adequately investigate and implement corrective actions to determine root causes and prevent recurrence of these contamination incidents.

your cleaning validation only tested for the absence of Gram-negative bacteria, but you have previously isolated fungi and gram-positive microorganisms from your water system

You failed to perform adequate incoming testing of each component lot used in the manufacture of your OTC drug products, such as Therabreath Mild Mint Toothpaste intended for use in children.

your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B)

After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.

you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm's compliance status with FDA.

Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.