Pharmacy Plus, Inc., dba Vital Care Compounder
FDA issued a warning letter to Pharmacy Plus, Inc., dba Vital Care Compounder (Hattiesburg, MS) following an October 2022 inspection that found serious insanitary conditions in sterile drug compounding operations, including microbial contamination in ISO 5 aseptic processing areas, use of non-sterile materials, inadequate media fills, and insufficient smoke studies. The firm had already initiated a voluntary recall of sterile drug products within expiry on October 7, 2022, but FDA found the corrective action responses incomplete and lacking supporting documentation. FDA cited violations of FDCA section 501(a)(2)(A) (adulterated drugs under insanitary conditions) and warned that failure to adequately address violations may result in seizure or injunction. The firm was required to respond within 15 working days with specific corrective steps and supporting documentation.
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. 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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