Tianjin Kilo Pharmaceutical Sci-tech 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

Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.

Passage 2

Failure to prepare and use master production and control records.

Passage 3

Failure to validate and verify the suitability of analytical methods.

Passage 4

Failure to design a documented, ongoing stability testing program to monitor the stability characteristics of APIs and to use the results to confirm the appropriate storage conditions and the retest or expiry dates.

Passage 5

Failure to list drugs in accordance with 510(j) of the FD&C Act, 21 U.S.C. 360(j), is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Furthermore, under section 502(o) a drug is misbranded if it is not included in a list required by section 510(j). Under section 301(a), the introduction or delivery for introduction into interstate commerce of any drug that is misbranded is prohibited.