FDA 483 - Hybrid Pharma LLC - September 03, 2021

This FDA Form 483 details multiple deficiencies observed during an inspection of an outsourcing facility. The facility failed to conduct adequate and comprehensive investigations into unexplained discrepancies and events. For instance, an investigation into particles found in Magnesium Chloride 200 mg/mL, Lot (b)(4), did not consider all potential contamination sources or extend to other batches. Similarly, a complaint regarding a missing label tracking number for Combo Drops Lot (b)(4) lacked a determined root cause and did not extend to other batches.

Method validation for ascorbic acid 500 mg/mL assay was found inadequate, as validation parameters were not performed on the actual method used for release testing. Environmental monitoring in aseptic processing areas was deficient, with personnel fingertip samples not consistently collected after processing small batches. Laboratory records lacked complete data from product release testing, including system suitability data.

The facility failed to retain reserve samples for drug products for one year past their expiration dates, as exemplified by the missing Magnesium Chloride, Lot (b)(4), sample. Furthermore, the outsourcing facility did not submit a comprehensive report to FDA upon initial registration, omitting numerous compounded drugs from their December 31, 2020, and June 30, 2021, reports. Finally, bulk drug substances were sourced from establishments not registered with the FDA, and one supplier's cyanocobalamin was indicated as "not for drug use."