# FDA 483 - Reliant Compounded Solutions Monroe, LLC - August 29, 2019

Source: https://www.keypedia.com/records/483/reliant-compounded-solutions-monroe-llc/16ff6a16-2030-4485-b2bd-91d2491c0a2e

> FDA 483 for Reliant Compounded Solutions Monroe, LLC on August 29, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reliant Compounded Solutions Monroe, LLC
- Inspection Date: 2019-08-29
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details nine observations from an inspection.

**Observation 1** notes the use of a non-pharmaceutical grade component, specifically a partially used, reconstituted 1-gram vial of Ceftazidime for Injection USP (NDC 44567-235-25, Lot 06072019). This single-dose vial, reconstituted on 6/7/19 with a 90-day Beyond Use Date (BUD), was subsequently used for sterile-to-sterile production of eye drops and intravitreal products on 6/7/19, 6/11/19, 7/8/19, and 8/5/19, each assigned a 14-day BUD. The Ceftazidime package insert states a 12-hour room temperature or 3-day refrigerated potency, or 3 months frozen at -20°C, and should not be refrozen once thawed.

**Observation 2** identifies difficult-to-clean, particle-generating, and visibly dirty equipment in ISO 5 aseptic processing areas. The hazardous ISO Class 5 Biological Safety Cabinet (BSC) had duct tape along the shield frame groove and cracks in the sash (shield).

**Observation 3** reports non-microbial contamination. Rust was observed on the exterior of both hazardous and non-

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Company: https://www.keypedia.com/companies/reliant-compounded-solutions-monroe-llc/8b9b45b5-124f-485c-9500-5c84f425c9e6

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c