FDA 483 - Symrise, S. de R.L de C.V. - July 22, 2018

During an FDA inspection from July 17-22, 2018, at Symrise, S. de R.L. de C.V., a manufacturer located in San Nicolas de los Garza, Nuevo Leon, Mexico, several observations were made.

**Observation 1: Lack of Quality Unit oversight and control of documents.** * There was insufficient control over the issuance of batch and production control records for drug product manufacturing. * Instrument identification numbers for API analysis were not documented in batch records or MYSAP analytical data. * QC analysts could delete raw chromatographic data files in Total Chrome software.

**Observation 2: Absence of written procedures for production and process controls.** * No written procedures existed for finished product labeling. * No written procedures for shipping crude (b)(4) to (b)(4) and QC release/return of finished API (b)(4). * No written procedures for QC release based on Certificate of Analysis for raw materials (b)(4) Powder and (b)(4) in (b)(4). * No written procedures for user rights and privileges of instrument software, such as Total Chrome.

**Observation 3: Failure to conduct process validation on drug manufacturing.** * The firm did not validate the number of times the (b)(4) process step could be repeated for the API (b)(4). * The number of times the