Sterling Pharmaceutical Services, LLC
Sterling Pharmaceutical Services, LLC, a contract manufacturer of sterile ophthalmic drug products in Dupo, Illinois, received an FDA Warning Letter citing significant CGMP violations including inadequate investigation of microbiological contamination in aseptic processing areas, insufficient environmental monitoring, and poor aseptic practices by personnel. The FDA also found that multiple sterile eye drop and ointment products bearing therapeutic claims (including homeopathic ophthalmic products) were unapproved new drugs marketed without FDA-approved applications in violation of sections 301(d) and 505(a) of the FD&C Act. The letter warns that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications.
Flagged claims (2)
Temporarily Relieves: ● (b)(4) ● (b)(4) ● (b)(4)
Supports: ● (b)(4)
Required actions (3)
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.
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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