FDA WARNING_LETTER - Tarmac Products, Inc. - September 27, 2019

On November 9, 2020, the FDA issued a Warning Letter to Tarmac Products Inc. following an inspection from September 9-27, 2019. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211) and Quality System (QS) regulations for medical devices (21 CFR part 820).

For drug products, violations included: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** Altered BioLumix microbiological testing results and overwriting original data, a repeat observation from 2015 and 2017. 2. **Inadequate Investigations (21 CFR 211.192):** Failure to investigate assay failures for OTC bisacodyl suppository lots, including root cause analysis and CAPA. 3. **Inadequate Stability Testing Program (21 CFR 211.166(a)):** Incomplete stability data for OTC drug products, including missing assay, identification, and antimicrobial effectiveness analyses, a repeat observation from 2015. 4. **Inadequate Equipment Calibration (21 CFR 211.68(a)):** Failing BioLumix equipment calibration results, a repeat observation from 2017,