FDA WARNING_LETTER - International Laboratories (Canada) Ltd. - February 16, 2012

On October 23, 2012, the FDA issued a Warning Letter to International Laboratories (Canada) Ltd. following a February 13-16, 2012 inspection. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Supplier Reliability (21 CFR § 211.84(d)):** The firm failed to validate supplier analyses or conduct specific identity tests for incoming components, relying solely on Certificates of Analysis. 2. **Specifications and Test Procedures (21 CFR § 211.160(b)):** The firm lacked scientifically sound specifications, sampling plans, and test procedures, including finished product specifications and identity/assay tests for their (b)(4) product. 3. **Quality Control Unit (QCU) Deficiencies (21 CFR § 211.22):** The QCU lacked established SOPs, oversight for finished product release, specifications for components, and failed to follow testing procedures for (b)(4). 4. **Master Production and Control Records (21 CFR § 211.186(b)):** Records lacked accurate component weights, theoretical yield statements, and complete manufacturing instructions. A change management program was also absent