FDA 483 - Alkem Laboratories Ltd - September 29, 2016

An FDA Form 483 was issued following an inspection, citing multiple observations regarding the facility's quality control, manufacturing, and distribution systems.

**Observation 1** notes that laboratory records lack complete data. Specifically, the QC laboratory does not report all test results from Out-of-Specification (OOS) investigations, contrary to internal procedures and USP guidelines, affecting products like [redacted] Capsules shipped to the US. Additionally, not all in-specification test results are reported, with instances of retesting and issuing new Certificates of Analysis (CoA) without including initial valid results.

**Observation 2** indicates the absence of a written stability testing program. The Quality Assurance unit failed to ensure stability data supports shelf-life dates and storage conditions. Discrepancies exist between the start date for assigning shelf life (API dispensing date) and the day zero for stability studies (batch release date). Batches are also not released in a timely manner to establish day zero for stability studies, with significant delays observed between packaging/initial testing and final batch release.

**Observation 3** highlights that container closure systems for [redacted] Solution [redacted] mg/mL exhibit batch [redacted] do not prevent product leakage, with control and stability samples showing leakage and discoloration.

**Observation 4** and **Observation 5** detail deficiencies in laboratory controls, specifically regarding scientifically sound specifications and sampling plans. API raw material samples are pooled prior to testing, and