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# FDA Flags Manufacturing/Labeling Violations at STAQ Pharma Ohio Facility
- URL: https://www.fdaweb.com/fda-flags-manufacturing-labeling-violations-at-staq-pharma-ohio-facility/
- Published: 2026-03-27T12:00:00.000Z
- Updated: 2026-09-14T13:36:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160893

FDA has issued an [untitled letter](https://www.fda.gov/media/191721/download?ref=fdaweb.com) to STAQ Pharma of Ohio, citing significant manufacturing, quality control, and labeling violations that could put patients at risk. The just-posted 12/5/2025 letter follows an FDA inspection conducted in May at the company’s Columbus, OH facility, which is registered as an outsourcing facility.

FDA investigators identified deficiencies in the company’s practices for producing sterile drug products, raising concerns about patient safety. The agency said some of the firm’s compounded drugs were produced under conditions that failed to meet current good manufacturing practice (CGMP) requirements. Among the violations cited:

- Failure to adequately investigate discrepancies or batch failures
- Lack of sufficient written procedures to ensure drug quality, strength, and purity

FDA also found that several compounded products — including phenylephrine hydrochloride and succinylcholine chloride formulations — were improperly labeled, lacking required information such as active and inactive ingredient lists. Because these products did not meet all conditions required under Section 503B, they are not eligible for exemptions typically granted to outsourcing facilities. As a result, the drugs may be subject to additional regulatory requirements, including premarket approval and stricter labeling standards.

The agency further determined that some products were misbranded, as their labeling did not provide adequate directions for safe use by non-medical consumers.