TMC Acquisitions LLC – FDA 483, Oct 24, 2018

This FDA Form 483 details observations from an inspection of a facility involved in sterile drug product manufacturing. The facility has documented five sterility failures since January 2016.

Key observations include: - **Inadequate Investigations:** Investigations into unexplained discrepancies and batch failures did not extend to other potentially associated batches or drug products. - **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination are not established or followed. A pharmacy technician was observed entering an ISO 7 room with ungloved hands before applying sanitizer and sterile gloves. - **Aseptic Processing Area Deficiencies:** - Systems for maintaining equipment used to control aseptic conditions are deficient. - Cleaning and disinfecting systems are deficient; a non-sterile bactericidal agent is used for cleaning ISO 5, 7, and 8 rooms. - Environmental monitoring is deficient, with personnel monitoring only conducted every (b)(4) and limited to fingertips, without documenting the time of monitoring or monitoring other areas. - **Labeling Control Issues:** Incorrect Beyond Use Dates (BUD) were observed on Tesamorelin 1 mg subcutaneous injection vials (batch 07161804), showing a one-year BUD instead of the correct 180 days. - **Product Release and Testing:** - Potency testing is performed at random intervals with no set schedule, and three products with Out-of-Specification (OOS) potency results were