Fagron Compounding Services, LLC dba Fagron Sterile Service
FDA issued a warning letter to Fagron Compounding Services, LLC dba Fagron Sterile Service, a 503B outsourcing facility in Wichita, KS, following a June 2024 inspection that found sterile drug products produced under insanitary conditions, CGMP violations, and labeling deficiencies that disqualified products from 503B exemptions. The facility's drug products were deemed adulterated (due to microbial contamination risks including a Chaetomium globosum recovery in an ISO 5 area and construction without adequate contamination controls), misbranded (lacking adequate directions for use), and unapproved new drugs. FDA acknowledged a voluntary recall of four lots of Lidocaine HCl Injection 2% for lack of sterility assurance and warned that failure to adequately address violations may result in seizure and injunction.
Flagged claims (5)
The drug product label did not include the dosage form. Examples include: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%, 5mL and Fentanyl Citrate 2mcg/mL (100mcg/50mL)/Ropivacaine HCl 0.15% (1.5mg/mL) (75mg/50mL).
You do not have any FDA-approved applications on file for drug products that you compound.
The container from which the individual units of the drug are removed for dispensing or for administration did not include directions for use, including, as appropriate, dosage and administration. Examples include: Epinephrine (1mg/mL), Sterile Solution for Injection; Phenol Injection 6% (60 mg/mL), in Sterile Water for Injection, 10 mL in Multi-Dose Vial; Sodium Citrate 4% (40mg/mL) containing Gentamicin 320mcg/mL Injection, 3mL, 5 mL, and 30 mL; and Dexamethasone Sodium Phosphate 10 mg/mL Solution for Injection, 2 mL in Multi-Dose Vial.
The drug product label did not include the established name of the drug. Examples include: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%, 5mL; Sodium Citrate 4% (40mg/mL) containing Gentamicin 320mcg/mL Injection, 3mL, 5 mL, and 30 mL; and Epinephrine (1mg/mL), Sterile Solution for Injection.
The drug product label did not include a list of active ingredients identified by established name. Examples include: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%, 5mL; Sodium Citrate 4% (40mg/mL) containing Gentamicin 320mcg/mL Injection, 3mL, 5 mL, and 30 mL; and Epinephrine (1mg/mL), Sterile Solution for Injection.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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