advanced botanical consulting & testing inc – FDA Warning Letter, Nov 13, 2018

The FDA issued a Warning Letter to Advanced Botanical Consulting and Testing Inc. dba ABC Testing (FEI 3003693795) following an inspection from November 1-13, 2018, at their Tustin, CA facility. The letter identifies significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Inadequate Test Methods:** The company failed to use USP monograph methods or demonstrate method equivalency/superiority for drug products like lidocaine, docusate, and fluocinolone. They also lacked suitability testing for microbiological methods, notably for *Burkholderia cepacia* (B. cepacia) in Diocto docusate sodium oral liquid stool softener, which was linked to a multi-state B. cepacia outbreak in 2016. This was a repeat violation from a 2012 inspection. 2. **Insufficient Documentation:** Notebooks and worksheets for analyses lacked lot numbers and expiration dates for standards, a repeat violation from 2012. 3. **Data Integrity Issues:** The firm lacked controls for electronic test data integrity, including disabled audit trails, no user restrictions on altering data, and shared "admin" logins. 4. **Equipment Malfunctions and Lack