483
Grato Holdings, Inc.Grato Holdings, Inc. – FDA 483, Dec 6, 2019
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.
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ID · 1cfb6b3e-d7ed-415c-bcc9-ec1f53aff862
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