FDA WARNING_LETTER - Shriram Institute for Industrial Research - October 22, 2019

The FDA issued a Warning Letter to Shriram Institute for Industrial Research, a contract testing laboratory in Delhi, India, following an inspection from October 15-22, 2019. The letter details significant violations of CGMP regulations for finished pharmaceuticals (21 CFR parts 210 and 211) and deviations from CGMP for active pharmaceutical ingredients (API), rendering their drugs adulterated.

Key violations include: 1. **Inadequate control over computer systems (21 CFR 211.68(a)):** The firm failed to enable audit trails on high-performance liquid chromatography (HPLC) units until the inspection was announced, a repeat observation from a 2016 inspection. The firm's response was deemed inadequate for lacking specific controls to ensure data integrity. 2. **Failure of the Quality Unit (QU) to follow procedures (21 CFR 211.22(d)):** The QU did not investigate out-of-specification (OOS) results unless requested by customers, and documentation errors (e.g., covering original values, non-contemporaneous recording, unrecorded sample IDs, unreviewed electronic data) were observed. The firm's response was inadequate for not including a risk assessment of these practices. 3. **Failure to ensure scientifically sound test procedures for API (API Deviations):** The firm tested USP-labeled materials without completing system suitability testing prior to