Diora Kimya Sanayi ve Ticaret Limited Sirketi

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 conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your** **component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 2

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

Passage 3

Your firm failed to perform appropriate testing on your drug product prior to release for distribution. You stated to our investigator that assay testing was not performed on approximately **(b)(4)** batches of your including **(b)(4)** distributed to the U.S. market between 2022 and 2024. Additionally, your firm transcribed component test results for **(b)(4)** and glycerin from your supplier’s COA directly to your finished product COA without confirmation of the results.

Passage 4

Your firm failed to establish 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 5

You failed to adequately validate your production and process controls used in the manufacture of your drug product. You have not completed process validation and cleaning validation studies for your non-dedicated equipment. Additionally, you lacked documentation that the equipment used to manufacture your drug product was qualified and suitable for its intended use.