Island Kinetics, Inc. d.b.a. CoValence Laboratories

Selected passages from the FDA letter

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

Passage 1

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Passage 2

Your firm did not have adequate cleaning validation studies for the equipment used to manufacture OTC drug products. For example, you lacked a documented rationale for the products selected for cleaning validation studies. Additionally, you lacked an analytical method to identify and measure specific drug residues to ensure that the cleaning process is effective in preventing cross-contamination between drug products manufactured on the same equipment.

Passage 3

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 4

Your firm failed to adequately investigate viscosity failures identified during stability testing of distributed OTC drug products. Specifically, stability testing records documented multiple viscosity out-of-specification (OOS) results without adequate root cause determination, CAPA, or documented justification for the established viscosity specifications.

Passage 5

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. 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. We may re-inspect to verify that you have completed corrective actions to address any violations.