Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil

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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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

You failed to adequately test your incoming components for identity before using the components to manufacture your over-the-counter (OTC) drug products. You also failed to adequately qualify your suppliers, as you have not validated the test results of your suppliers’ analyses and instead relied on your suppliers’ responses to your vendor questionnaire.

Passage 3

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 4

Your firm 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 211.166(a)).

Passage 5

You failed to demonstrate that you established and followed an adequate stability program to determine appropriate storage conditions and expiration dates of drug products manufactured at your facility. For example, your stability program lacked appropriate testing of your drug products, including testing of active ingredients, impurities, and other degradation products.