Cosco International, 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 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

You failed to perform appropriate cleaning validation studies for non-dedicated equipment used to manufacture your OTC drug products. For example, you manufacture products on shared equipment using active ingredients such as Menthol, Benzalkonium Chloride, Lidocaine, or Ketoconazole, in addition to cosmetic products. You failed to demonstrate that your cleaning procedures can prevent potential cross-contamination between the various drug and cosmetic products mixed and filled on the same shared equipment.

Passage 3

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (211.166(a)).

Passage 4

Your firm did not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products met established specifications and remain acceptable throughout their labeled shelf-life. For example, you distributed drug products intended for wound treatment in children without conducting accelerated or long-term stability studies.

Passage 5

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (211.160(b)).

Passage 6

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.