# FDA 483 - Fresenius Kabi USA, LLC - July 08, 2011

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/a396774c-8281-464e-859d-99698920571c

> FDA 483 for Fresenius Kabi USA, LLC on July 08, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA, LLC
- Inspection Date: 2011-07-08
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection conducted at APP Pharmaceuticals, LLC, a sterile drug manufacturer in Grand Island, NY, from June 13 to July 8, 2011, revealed significant deviations from Current Good Manufacturing Practice (cGMP) regulations. The inspection identified numerous systemic issues spanning quality systems, facility controls, laboratory operations, and post-market reporting. Key findings included a widespread failure to thoroughly investigate over 400 customer complaints since January 2010, involving critical issues such as particulate matter, product discoloration, cracked/leaking vials, and foreign objects like insects. The company did not consistently perform initial impact assessments or adequately attempt to collect complaint samples, nor did it file required NDA-Field Alert Reports for these significant product quality concerns. Further observations highlighted inadequate environmental controls, with multiple instances of insect contamination in aseptic manufacturing areas. Procedures designed to prevent microbiological contamination, such as media fill documentation and vent filter integrity testing, were found deficient or not followed. Laboratory controls were also cited for scientifically unsound sampling plans, insufficient acceptance criteria for particulate matter testing, and the use of unverified analytical methods and computer systems. Records for returned drug products were not properly maintained, and master production records lacked complete instructions, leading to deviations. The FDA requires APP Pharmaceuticals, LLC to address these serious compliance deficiencies with comprehensive corrective and preventive actions to ensure the safety, quality, and integrity of its sterile drug products.

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## Related Officers

- [Branch Chief, Foreign Pharmaceutical Quality Inspection at FDA](https://www.keypedia.com/people/kevin-a-gonzalez/3f0a5230-3804-4df2-9a5e-3ea805ba9b79)
- [James D. Bridges](https://www.keypedia.com/people/james-d-bridges/8ce30e52-4b32-4d12-84a2-b2a9ce8f6f53)
- [Chemist at US Department of Health and Human Services](https://www.keypedia.com/people/felix-maldonado/d7a5c4bd-2aa7-405f-b3c4-17ef35152ab4)

Company: https://www.keypedia.com/companies/fresenius-kabi-usa-llc/f0c47fa1-3b76-4e6c-82dd-d703086bdfdc

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c