FDA WARNING_LETTER - LNK International, Inc. - February 08, 2019

The FDA inspected LNK International, Inc.'s drug manufacturing facility from January 23 to February 8, 2019, identifying significant CGMP violations, rendering their drug products adulterated.

Violations include: 1. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** Four lots of Diphenhydramine 50 mg Berry Syrup were released despite initial out-of-specification (OOS) microbial counts (TAMC and TCYMC). The firm's investigation confirmed OOS results but released lots based on additional samples, failing to adequately address contamination or its hazards. A recall of four lots due to microbial contamination was acknowledged. * **Required Actions:** Retrospective, independent review of all invalidated OOS results, comprehensive assessment of manufacturing operations for microbiological hazards, detailed risk assessment for distributed contaminated products, complete investigations into all lots with potential microbial contamination, and a comprehensive remediation plan for OOS investigation systems and overall deviation/discrepancy investigation systems.

2. **Failure to establish adequate laboratory controls (21 CFR 211.160(b)):** The firm lacked sufficient specifications and analytical testing procedures for critical quality attributes, including dissolution and 4-Aminophenol impurity testing for acetaminophen-containing drug products. * **Required Actions:** Provide a list of all chemical and microbial test methods/specifications, an assessment to ensure complete specifications