FDA 483 - Crawford's Professional Drugs, Inc. dba Diket's Professional Drugs, Inc. - November 29, 2018

An FDA inspection of Crawford's Professional Drugs, Inc. dba Diket's Professional Drugs, Inc., a producer of non-sterile drugs located at 240 S. 13th Ave, Laurel, MS, was conducted from November 26-29, 2018. The inspection, led by Investigator Joanne E King, identified five observations.

Observation 1 noted inadequate containment, segregation, and cleaning procedures for highly potent drugs, specifically fluorouracil, leading to potential cross-contamination. Reusable equipment was cleaned with municipal water and soap, and surfaces wiped with an undisclosed solution, without documented effectiveness for residue removal.

Observation 2 similarly cited inadequate containment and cleaning for hazardous drugs, including hormones like testosterone and progesterone. Reusable equipment and work surfaces, cleaned with municipal water and soap, lacked documented effectiveness for neutralizing drug residues.

Observation 3 highlighted insufficient glove changes by personnel, leading to contamination. Visible progesterone powder on gloves was transferred to "compounding room" stools and computer equipment during drug preparation.

Observation 4 indicated poor facility design and operation, allowing for improper flow of personnel and materials. Used utensils and a capsule machine with visible progesterone powder were placed on "compounding room" stools, with no designated area for used equipment to prevent cross-contamination.

Observation 5 stated that a drug product, progesterone 150 mg sustained release capsules lot BCBBCABH@8, was released despite potency testing on