Sato Pharmaceutical Co., Ltd.

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 and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic processes (21 CFR 211.113(b)).

Passage 2

Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms. Your firm also failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.165(b) and 21 CFR 211.166(a)).

Passage 3

Your firm did not have an adequate stability program to demonstrate that the chemical and microbiological properties of your drug products met established specifications and that they remain acceptable throughout their labeled shelf-life.

Passage 4

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that your (b)(4) OTC drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).