# FDA 483 - STAQ Pharma of Ohio, LLC - May 16, 2025

Source: https://www.keypedia.com/records/483/staq-pharma-of-ohio-llc/2744c4c0-e217-4c53-b31e-5e23c6a838af

> FDA 483 for STAQ Pharma of Ohio, LLC on May 16, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: STAQ Pharma of Ohio, LLC
- Inspection Date: 2025-05-16
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of STAQ Pharma of Ohio, LLC, an outsourcing facility located at 255 Phillipi Rd, Columbus, OH, was conducted from May 6-16, 2025. The inspection identified three observations.

Observation 1 notes a failure to thoroughly review batch failures. Specifically, the firm did not investigate the root cause of critical defects, including particulate matter, found during visual inspections of Dexmedetomidine Hydrochloride 4 mcg/mL, 5mL in a 5mL syringe, Lot [b][4]. Despite an initial 100% visual inspection identifying 85 defects (74 critical) and a subsequent failed AQL inspection, no root cause investigation was initiated. A second 100% visual inspection found 94 defects (87 critical), yet the lot was released and distributed. The orange particulate matter was not characterized, and no corrective actions were implemented.

Observation 2 states the firm failed to establish adequate written procedures for production and process controls. The "Sampling Plans" SOP-0052 does not define reinspection parameters, lacks scientifically sound acceptance criteria post-reinspection, and does not require rejection of lots failing initial AQL. The "Visual Inspection – OH" SOP-0012 lacks acceptance criteria for defect categories (critical, major, minor) and does not require defect trending. Additionally, the use of [b][4] for inspecting colored (amber)

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Company: https://www.keypedia.com/companies/staq-pharma-of-ohio-llc/9f54df47-7540-468d-be3f-3c94598da495

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