FDA 483 - dca, inc., - October 18, 2016

The FDA Form 483 inspection revealed significant deficiencies at a drug manufacturing facility producing hormones, teratogenic materials, antibiotics, and controlled substances.

**Equipment and Cleaning Issues:** * Equipment and utensils are not cleaned and sanitized at appropriate intervals. * The firm lacks cleaning validation data for (b)(4) and (b)(4) as cleaning agents for drug production equipment. * (b)(4) is used for cleaning without purified water as a final rinse.

**Cross-Contamination and Facility Design:** * The flow of materials is not designed to prevent contamination. * Potent drug substances (hormones, teratogenic materials, antibiotics, controlled substances) are handled without adequate containment, segregation, or cleaning of work surfaces, equipment, and personnel, leading to cross-contamination risks in the general pharmacy (including shared hoods, (b)(4)). * A teratogenic drug (Allopurinol/Colchicine) was produced in the same hood and with the same equipment as other drugs (Prednisolone Liquid) without cleaning validation data.

**Complaint Investigations:** * Complaint investigations are inadequate and not always completed. * Specific examples include: * A burning sensation complaint for Estriol 0.5mg/mL Vag with no documented investigation. * A complaint of abnormal bleeding and breast lumps for Progesterone 300mg, which was not