# FDA 483 - Allergan Sales, LLC - June 22, 2015

Source: https://www.keypedia.com/records/483/allergan-sales-llc/f79a54ac-fe57-4f0a-9220-80c8151e0115

> FDA 483 for Allergan Sales, LLC on June 22, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allergan Sales, LLC
- Inspection Date: 2015-06-22
- Product Type: Drugs
- Office Name: Food and Drug Administration
- Summary: During an inspection conducted from June 22 to July 10, 2015, the U.S. Food and Drug Administration (FDA) identified significant deviations at Allergan Sales, LLC"s human drug manufacturing facility in Waco, Texas. These observations indicate a failure to adhere to Current Good Manufacturing Practices (CGMP) for pharmaceutical production, particularly concerning quality control and aseptic processing. Key issues highlighted in the FDA Form 483 report include systemic failures in thoroughly investigating unexplained discrepancies and product failures. Specifically, the company initiated late and incomplete investigations into a rising trend of particle contamination in sterile ophthalmic ointments, leading to adverse event complaints. Similarly, investigations into mold contamination in other ophthalmic products were inadequate, prematurely attributing issues to end-user misuse without examining manufacturing processes or preservative system effectiveness. The inspection also found a lack of investigation into critical facility issues, such as HEPA filter leaks and out-of-specification airflows in sterile filling areas, and a deficient procedure for assessing their impact. Furthermore, several analytical testing discrepancies and out-of-specification results were erroneously dismissed as "lab error" without proper scientific justification. Additionally, the FDA observed non-compliance with established procedures designed to prevent microbiological contamination during cleaning operations in aseptic processing areas. These included improper cleaning agent usage, direct contact with cleaned surfaces, incomplete sanitization of critical areas, and missed cleaning spots on equipment. Allergan Sales, LLC is required to implement comprehensive corrective and preventive actions to address these observations, ensuring the integrity, sterility, and quality of its drug products and establishing robust quality system controls.

## Related Documents

- [483 - 2015-07-10](https://www.keypedia.com/records/483/allergan-sales-llc/0505126c-fca5-4117-b3bd-11b1204606c2)
- [483 - 2015-10-08](https://www.keypedia.com/records/483/allergan-sales-llc/e9b4bc9b-ce35-4ebf-8179-ff221959c3ee)
- [483 - 2016-10-28](https://www.keypedia.com/records/483/allergan-sales-llc/e3c1349c-5578-4f6c-b329-fbee3723c6f6)
- [483 - 2019-02-27](https://www.keypedia.com/records/483/allergan-sales-llc/209b505c-c846-4bd9-acbb-c413676c87f2)

## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)
- [Investigator](https://www.keypedia.com/people/shelby-n-marler/2cbb1b1c-ad36-4385-b61f-bee80ad8e1bd)
- [Clinical Trials Associate](https://www.keypedia.com/people/rebeca-rodriguez/6dc44559-b1bf-44ac-95f3-af5fa8a4acd7)
- [Biologist at CBER](https://www.keypedia.com/people/massoud-motamed/a8b363de-eb95-4bd3-8c05-9c34bbdbdc8a)

Company: https://www.keypedia.com/companies/allergan-sales-llc/dced41da-32c6-41b1-829c-6287550c2c71

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516