FDA WARNING_LETTER - Deva Holding AS - Cerkezkoy Subesi - February 15, 2019

The FDA inspected Deva Holding AS – Cerkezkoy Subesi in Turkey from February 4-15, 2019, identifying significant CGMP violations, rendering their drug products adulterated. The facility manufactures drugs on two campuses, CK1 and CK2, with penicillin and non-beta-lactam products made on CK2.

A key violation was inadequate controls to prevent penicillin cross-contamination. Penicillin was detected 103 times in 2017, 44 in 2018, and 9 in 2019 (through June) outside penicillin manufacturing areas on CK2, including in the building where non-beta-lactam (b)(4) capsules for the U.S. market are made (7 times). Penicillin was also found in common dining areas accessible to all employees, including one instance on an employee's clothing. The firm's routine monitoring was inadequate, not including (b)(4) capsule production areas until after an Import Alert. Their decontamination solutions lacked effectiveness data.

The firm's March 6, 2019, response was deemed inadequate. While they tested retain samples of (b)(4) capsules for penicillin, the analytical method's limit of detection (LOD) of (b)(4) ppb was insufficient; FDA's method has a 0.2 ppb LOD. The response also lacked a comprehensive reassessment of contamination and