Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim 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

You failed to adequately test your incoming **(b)(4)**, used as an active pharmaceutical ingredient, for **(b)(4)**. The use of **(b)(4)** contaminated with **(b)(4)** has resulted in various lethal poisoning incidents in humans worldwide. **(b)(4)**.

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

You failed to adequately validate your production and process controls used in the manufacture of your OTC drug products. You also lacked adequate documentation that the equipment used to manufacture and test your drug product was qualified and suitable for its intended use.

Passage 5

Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products. (21 CFR 211.166(a)).

Passage 6

Your firm did not establish an adequate ongoing stability testing program to demonstrate that your OTC drug products met established specifications for identity, strength, quality, and purity for the duration of their labeled **(b)(4)** shelf lives.