# FDA 483 - Catalent Pharma Solutions LLC - September 28, 2020

Source: https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/d05d9a0f-3217-4bac-94c9-f97a63c84ecd

> FDA 483 for Catalent Pharma Solutions LLC on September 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Pharma Solutions LLC
- Inspection Date: 2020-09-28
- Product Type: drugs
- Office Name: FDA District Office — Atlanta, Georgia
- Summary: An FDA inspection of Catalent Pharma Solutions LLC in Morrisville, NC, revealed significant deficiencies in the firm's design control procedures for their Albuterol Sulfate Inhalation Aerosol, 90 µg combination device. The company failed to adequately establish and maintain plans and procedures for design validation, verification, input, output, and overall design and development activities. These observations indicate a systemic lack of adherence to regulatory requirements for combination product design controls.

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Company: https://www.keypedia.com/companies/catalent-pharma-solutions-llc/1080c7fd-2536-4ea5-9a11-18fc6317081b

Office: https://www.keypedia.com/offices/fda-district-office-atlanta-georgia/bae3b8c4-4161-4e9f-b5d1-e0e80b6abd43