Grato Holdings, Inc.December 6, 2019

FDA 483 - Grato Holdings, Inc. - December 06, 2019

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Record Details

Grato Holdings, Inc. in Woodbine, IA, was inspected from December 2-6, 2019, and received a Form 483 with six observations. The inspection revealed significant deficiencies in method validation for microbial testing, inadequate cleaning validation, and issues with raw material sampling. Additionally, the firm failed to ensure product identity and strength, properly investigate customer complaints, and maintain complete records of testing method modifications.

Company: Grato Holdings, Inc.
Inspection Date: December 6, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
People: Jacob G. Lutz (Investigator)
Emilie E. Kahn (Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality)

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ID · 1cfb6b3e-d7ed-415c-bcc9-ec1f53aff862