FDA 483 - Home Care Pharmacy of Palm Coast, Inc. - April 25, 2018

This FDA Form 483 documents observations from an inspection concerning the production of drug products. The facility produced hazardous drugs, specifically prescription (b)(6) (estrogen and testosterone vaginal cream) and Methimazole 2.5mg/0.1mL, Lot 042418A, without adequate containment, segregation, and cleaning of work surfaces to prevent cross-contamination.

On April 24, 2018, during the production of these drugs, the scale used for weighing ingredients, including active ingredients methimazole, estrogen, and testosterone, was not cleaned between uses. Furthermore, the hood utilized for producing these drug products was not entirely cleaned between the production of each drug product.

The facility also produced beta-lactam drugs without adequate containment, segregation, and cleaning of work surfaces to prevent cross-contamination. Beta-lactam drug products were produced in the same hood as other drug products without appropriate segregation and cleaning of the hood and equipment. For instance, on April 17, 2018, the firm produced prescription (b)(6) for Amoxicillin 125mg/mL, which was then followed by the production of prescription (b)(6) for Progesterone in the same area. These observations indicate deficiencies in preventing cross-contamination of drug products, particularly between hazardous/beta-lactam drugs and other drug products.