# FDA 483 - Resilience US, Inc. - December 23, 2009

Source: https://www.globalkeysolutions.net/records/483/resilience-us-inc/692c58e3-a3a2-4a48-9047-947fe1547fd4

> FDA 483 for Resilience US, Inc. on December 23, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resilience US, Inc.
- Inspection Date: 2009-12-23
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Amylin Pharmaceuticals Inc., a pharmaceutical manufacturer located at 8814 Trade Port Dr, West Chester, OH 45071, was conducted from December 7 to December 23, 2009. The inspection revealed ten observations regarding the firm's compliance with manufacturing and quality control regulations.

Key observations include:
1.  **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established and followed. Specifically, media fills simulating the commercial automated inspection process (including vibrator/shaker table) have not been completed, with all ten performed media fills undergoing manual visual inspection.
2.  **Laboratory Control Documentation:** Established laboratory control mechanisms are not documented at the time of performance. A contractor with a cast on his arm was signed off as having adequately demonstrated gowning procedures for aseptic area entry, despite it being impossible, and Quality Control failed to review these records or initiate an investigation.
3.  **Production and Process Control Procedures:** Written production and process control procedures are not followed. There is no SOP addressing who can disable alarms, under what circumstances, or who is responsible for such decisions. An AIT-21201 alarm (detecting high Total Organic Carbon in hot water-for-injection distribution loop) was disabled by the facilities department at the instruction of the QA Director without a governing SOP.
4.  **In-process Material Testing:** In

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## Related Officers

- [Elizabeth Loreaux](https://www.globalkeysolutions.net/people/elizabeth-loreaux/25116a71-3367-4676-a86c-94833fcdb5c7)
- [Cherrie A. Zachary](https://www.globalkeysolutions.net/people/cherrie-a-zachary/4d605d81-0b8d-47ed-a33b-15b07b0299a4)
- [Nicholas L. Paulin](https://www.globalkeysolutions.net/people/nicholas-l-paulin/a8e0649a-614f-499b-8fdc-1217f7d71887)
- [Anna M. Brannen](https://www.globalkeysolutions.net/people/anna-m-brannen/b8513ae4-9182-4024-94e4-dea1da4341be)

Company: https://www.globalkeysolutions.net/companies/resilience-us-inc/864cabb1-d73c-4706-8d04-3e5c2375f44e

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22