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FDA Warning Letter Explorer
FDA warning letter · Drugs

Taizhou Kangping Medical Science and Technology Co., Ltd.

Issued · Posted by FDA

Selected passages from the FDA letter

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

Passage 1

Failure to establish procedures designed to prevent micro-contamination in products purporting to be sterile (21 CFR 211.113(b)).

Passage 2

Failure to establish appropriate product specifications and scientifically sound testing procedures (21 CFR 211.160(b)).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 210
  • 21 CFR 211.113(b)
  • 21 CFR 211.160(b)
  • 21 CFR 211