# FDA 483 - Kindeva Drug Delivery L.P. - April 03, 2024

Source: https://www.globalkeysolutions.net/records/483/kindeva-drug-delivery-lp/841e07bb-85ce-4f0e-8ae1-77de071953dc

> FDA 483 for Kindeva Drug Delivery L.P. on April 03, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kindeva Drug Delivery L.P.
- Inspection Date: 2024-04-03
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Kindeva Drug Delivery LP in Woodbury, MN, a contract testing laboratory, was cited for significant deficiencies during an FDA inspection. The observations include a lack of scientifically sound laboratory test procedures, inadequate written procedures for the quality control unit, and a failure to maintain backup files for electronic raw data. These issues primarily impact the testing and data integrity for albuterol sulfate MDI.

## Related Officers

- [Tyler M. Peterson](https://www.globalkeysolutions.net/people/tyler-m-peterson/207310ee-260c-4618-a515-9895a56e2ede)
- [Beatriz I Arevalo](https://www.globalkeysolutions.net/people/beatriz-i-arevalo/e2a9ca1f-fd02-4fd2-82fb-a77caf7aac5e)
- [Drug Specialist](https://www.globalkeysolutions.net/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)

Company: https://www.globalkeysolutions.net/companies/kindeva-drug-delivery-lp/0646cae7-379e-4079-b6b7-0ca8e6026087

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d