FDA 483 - AstraZeneca Pharmaceuticals, LP - January 30, 2017

This FDA Form 483 documents observations from an inspection of ZS Pharma, Inc., an API Manufacturer located at 508 Wrangler Dr Ste 100, Coppell, TX 75019 (FEI Number 3010199915). The inspection was conducted from January 18-30, 2017. The report was issued to Mr. John S. Strokis, Head of Quality.

Six observations were noted:

1. **Process Validation Deficiencies:** Process validation procedures for (b)(4) API did not predefine batches subject to validation, and the quality unit's authority to accept or reject batches was not ensured. Validation protocols and batch records lacked documentation specifying prospectively chosen batches. 2. **Facility and Equipment Maintenance Issues:** Reactor (b)(4) had a worn-out gasket with loose threads and black particulates, along with black, white, and red residues. Reactor (b)(4) exhibited tearing of the head gasket, with missing portions and warping, and the gasket material and potential product impact could not be ascertained. 3. **Unjustified Specification and Investigation Failure:** The specification for (b)(4) ((b)(4) - (b)(4) designated (b)(4)) was not justified for the (b)(4) manufacturing process. The firm failed to investigate elevated (b)(4) values upon scale