Stokes Healthcare Inc. dba Epicur Pharma
FDA issued a warning letter to Stokes Healthcare Inc. dba Epicur Pharma, a 503B outsourcing facility in Mount Laurel, NJ, following a September–October 2023 inspection that revealed sterile drug products were produced under insanitary conditions and failed to meet CGMP requirements, rendering them adulterated under section 501(a)(2)(A) and (B) of the FDCA. Specific violations included inadequate sterilization testing, deficient media fills and smoke studies, insufficient sporicidal dwell times, and failure to investigate an adverse trend of Mucor circinelloides fungal contamination in ISO 8 cleanrooms while continuing to distribute affected drug products. The facility also failed to meet section 503B labeling conditions (missing inactive ingredient quantities and adverse event reporting information) and did not submit adverse event reports per 21 CFR 310.305, causing products to be misbranded. FDA demanded a written corrective action response within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (4)
your documented Standard Operating Procedures (SOPs) for reporting adverse events do not state that a follow-up report is to be submitted to FDA within 15 calendar days of receipt of new information or as requested by FDA (21 CFR 310.305(c)(2)).
some of your facility's drug products, such as Tacrolimus (AQ) 0.5% Ophthalmic Suspension 10mL and Fluorouracil (AQ) PF 50mg/mL Injection Solution 50ms, did not include the following information on the container: Information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088.
you list inactive ingredients proportionally from largest to smallest on your product labels and that each label states "INACTIVE(S) (proportional from largest to smallest amount)", but such a list does not provide the quantity or proportion of each inactive ingredient.
Some of your facility's drug products, such as various strengths of Tacrolimus (Aqueous) Ophthalmic Suspensions did not include the following information on the label: The quantity or proportion of each inactive ingredient.
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.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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.
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