Medi-Fare Drug & Home Health Center, Inc. — FDA 483 Findings

There are no written procedures and documentation thereof addressing the subsequent stability, microbial and potency characteristics of stock solutions throughout their labeled Beyond-Use Date, from which multiple aliquots are withdrawn to prepare additional sterile formulations.

Your firm cites USP <797> and USP <71> as their guidance for sterility and endotoxin testing requirements.

There is no documentation that supports the extension of the BUD dates outside of the duration of therapy.

(a).Your firm failed to thoroughly investigate the QREs (Quality Related Events) for Epinephrine 1: 1000 PF Sulfite Free Injectable lots 20121018@9 and 20121024@8 and dispensed from 11/2-11/7/12 with reported pink discoloration, which resulted in the recall of both lots.

Formulation worksheets are not sufficiently reviewed to ensure accurate and complete information is recorded.

Vials used in filling sterilized prepara tions have not b een rendered free from viable microbes through the use of a validated REDACTED (B) (4) cycle.

Sterility assurance parameters were not met due to your failure to adequately evaluate your REDACTED (B) (4) define appropriate parameters for drug product sterilization, and maintain documentation of sterilization.

There is no documentation of any investigations conducted for over 150 compounded preparations and raw materials that were identified as being "Out of Spec", "Not Pass QA", or Rejected" on destruction logs dated 12/4-7/12.

Distribution of the Testosterone Aqueous Suspension 50mg/ml inj., Lot 20120515@3 occurred prior to receipt of final product test results.

Records documenting the dates, load cycle, and lot number of vials washed and REDACTED (B) (4) are not been being maintained.

The current system for monitoring environmental conditions existing within the aseptic processing areas is deficient.