FDA 483 - Lupin Limited - October 18, 2018

This FDA Form 483 details observations from an inspection, highlighting deficiencies in manufacturing processes, quality control, and record-keeping.

**Observation 1** notes a lack of established control procedures to monitor output and validate manufacturing process performance. Specifically, a Process Performance Qualification (PPQ) study was deficient as it excluded a failed second exhibit batch (lot #) for a 1 mg product. The facility initially misidentified this batch as a development batch before admitting it was a failed second exhibit batch.

**Observation 2** identifies inadequate written procedures for cleaning and maintenance. Cleaning validation and verification for filling rooms and equipment are deficient, particularly for a multi-use production room and dedicated equipment used for potent drug products, raising cross-contamination concerns. The facility provided inconsistent explanations regarding their cleaning validation approach.

**Observation 3** points to insufficient controls over computer systems, specifically in the QC laboratory. The QC laboratory Manager has unauthorized modification permissions for HPLC and GC system sequences, and the QC reviewer does not adequately review these modifications or their audit trails. Traceability for these permissions is also lacking.

**Observation 4** indicates deficient sampling procedures for APIs, as samples are not collected from the top, middle, and bottom of material containers.

**Observation 5** states that procedures for acceptance of incoming products are inadequate. A functional test is not performed on a received device used for drug delivery before its release.

Finally, an additional **Observation 3** (re-