# FDA 483 - Compound Care Pharmacy LLC - May 16, 2019

Source: https://www.keypedia.com/records/483/compound-care-pharmacy-llc/e16383eb-800c-4b13-8914-5b1df75b9799

> FDA 483 for Compound Care Pharmacy LLC on May 16, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Compound Care Pharmacy LLC
- Inspection Date: 2019-05-16
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: Compound Care Pharmacy, a sterile compounding pharmacy, was inspected by the FDA from May 13-16, 2019. The inspection resulted in the issuance of a Form FDA 483, detailing two significant observations concerning product quality and facility controls.

The primary issue identified was the release of intrathecal drug products lacking assurance of safe bacterial endotoxin (BET) levels. The firm utilized non-sterile active pharmaceutical ingredients (APIs) such as baclofen, bupivacaine, clonidine, hydromorphone, and morphine sulfate without BET testing results on their Certificates of Analysis. Compounding this, the pharmacy did not perform BET testing on its final intrathecal drug products, leading to a lack of assurance regarding their freedom from bacterial endotoxins.

Additionally, the inspection noted that disinfecting agents and cleaning wipes used within the critical ISO 5 cleanroom area were not sterile. The use of non-sterile cleaners presents a significant risk of microbial contamination to the sterile production environment and, consequently, to the compounded sterile products themselves.

These observations highlight deficiencies in quality control and environmental monitoring practices, which are crucial for ensuring the safety and sterility of compounded medications. Compound Care Pharmacy is expected to respond to the FDA with a plan for corrective actions to address these findings and bring their operations into compliance with regulatory expectations for sterile compounding.

## Related Officers

- [Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/adam-r-cooke/337c005d-e9dc-4512-aadb-ee0b0c637bd5)

Company: https://www.keypedia.com/companies/compound-care-pharmacy-llc/58ac649c-a548-4f2a-b7e4-3c0298bc8c6d

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22