FDA Inspection 1235569 - Kindeva Drug Delivery L.P. - April 03, 2024

Record Details

This FDA Inspection record concerns Kindeva Drug Delivery L.P., with an inspection on April 3, 2024, issued by the Minneapolis District Office, covering human drugs.

Company: Kindeva Drug Delivery L.P.
Inspection Date: April 3, 2024
Product Type: Human Drugs
Office: Minneapolis District Office
People: Beatrix D. Hippe (Investigator)
Lauren N. Howard (FDA Associated Person)
Tyler M. Peterson (Issuing Officer)

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ID · ee093622-3fbb-410e-bd55-5e95941c436e

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1235569
FDA center: Human Drugs
Project area: New Drug Evaluation
Outcome: Form 483 issued

FDA Citations

21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.68(b)Backup file not maintained

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FDA Inspection

Kindeva Drug Delivery L.P.April 3, 2024