Hanmi Science Co., Ltd. – FDA Inspection, Nov 8, 2024

Record Details

This FDA Inspection record concerns Hanmi Science Co., Ltd., with an inspection on November 8, 2024, issued by the Office of Inspections and Investigations, covering foods & cosmetics.

Company: Hanmi Science Co., Ltd.
Inspection Date: November 8, 2024
Product Type: Foods & Cosmetics
Office: Office of Inspections and Investigations
Person: Kibily D. Dembele (Issuing Officer)

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ID · 2387b143-463e-4256-8ba6-18411102712a

Inspection Facts

Inspection number: 1253927
FDA center: Foods & Cosmetics
Project area: Foodborne Biological Hazards
Outcome: Form 483 issued

FDA Citations

21 CFR 108.35(c)(3)(i)Process adherence
21 CFR 108.35(g)Approved school
21 CFR 113.40(g)(1)(i)(B)Recorder sensor - product holding tube
21 CFR 113.40(g)(1)(i)(I)Operator monitor seals, barriers (S)
21 CFR 113.40(g)(1)(ii)(A)Startup - commercial sterility
21 CFR 117.135(a)(1)Process preventive controls - Identify (Written)

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FDA Inspection

Hanmi Science Co., Ltd.November 8, 2024