FDA 483 - DNA Pharmacy Services Inc dba Palm Beach Compounding - May 23, 2017

This FDA Form 483 documents observations made during an inspection concerning the production of hazardous and non-sterile drug products. The facility produces hazardous drugs and non-sterile drug products containing hormones like testosterone and progesterone.

A key observation is the inadequate cleaning of utensils and work surfaces, which poses a risk of cross-contamination. Specifically, a (b) (4) used for (b) (4) (b) (4) was stored in alcohol between uses instead of being properly cleaned with detergent and sanitized. The facility lacks documentation to support the cleaning practices and maintenance of this (b) (4).

Furthermore, reusable equipment used for non-sterile hormone-containing drug products was cleaned with a (b) (4) with (b) (4) detergent or (b) (4) with (b) (4) (b) (4) soap. Working surfaces were wiped down using (b) (4) (b) (4). The facility does not possess documentation to demonstrate the effectiveness of these cleaning methods in removing and neutralizing drug residues. An example provided is the use of Testosterone (b) (4), lot (b) (4), drug substance to prepare Test/DHEA/Prog/Anastrozole troche butterscotch 110/10/5.0/5mg, lot 04/21/2017:0308.

The observations indicate deficiencies in cleaning validation and