Central Admixture Pharmacy Services, Inc. – FDA 483, Sep 11, 2018

This FDA Form 483 was issued to Central Admixture Pharmacy Services Inc., an Outsourcing Facility located at 7935 Dunbrook Rd Ste c, San Diego, CA 92126-6322. The inspection was conducted from August 27, 2018, to September 11, 2018. Bhavya B. Sharma, Director of Pharmacy, was the individual to whom the report was issued.

The inspection revealed six observations:

1. **Procedures to prevent microbiological contamination of sterile drug products are not established.** Specifically, the firm has not adequately established proper aseptic technique in the extraction of contents from drug product vials or in the sealing of IV bags during filling. For example, different techniques were observed for extracting vial contents, with only one allowing for proper first air from HEPA filters. 2. **Separate or defined areas to prevent contamination or mix-ups are deficient regarding aseptic processing.** The design and operations in the ISO Class 7 room do not always provide adequate spacing, leading to disruptions in production. 3. **Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.** Environmental monitoring of ISO Class 5 hoods is not adequate to assure cleanroom operations are met during operations. 4. **Written procedures are lacking for the receipt of components, drug product containers, and closures.** SOP-CAPS-4000157