Chemical Services Group, Inc./Royal Chemical Company
FDA issued a warning letter to Chemical Services Group, Inc./Royal Chemical Company (Macedonia, OH / East Stroudsburg, PA) following a November 2022 inspection of their drug manufacturing facility. The agency found significant CGMP violations including manufacturing OTC hand sanitizer drug products on equipment shared with industrial chemicals, failure to validate ethanol supplier test analyses, inadequate batch release testing (missing methanol and benzene impurity checks), and a quality control unit that failed to exercise proper oversight. FDA warned that failure to correct these violations could result in seizure, injunction, or withholding of export certificates and new drug application approvals.
Required actions (4)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction.
FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
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