Adept Life Science, LLC

Warning LetterOpen

Mr. Michael T. Shields and Ms. Windy N. Shields Owners Adept Life Science, LLC 2215 E Germann Rd Chandler , AZ 85286 United StatesFEI 3013930557Issued Jan 24, 2023Division of Human and Animal Food Operations East IV

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013930557.

Violations11

Issue DateJan 24, 2023

Product TypeDietary Supplements

StatusOpen

Letter Details

Firm: Adept Life Science, LLC
Location: Mr. Michael T. Shields and Ms. Windy N. Shields Owners Adept Life Science, LLC 2215 E Germann Rd Chandler , AZ 85286 United States
FEI Number: 3013930557
Country: United States
Issue Date: January 24, 2023
Issuing Office: Division of Human and Animal Food Operations East IV
Product Type: Dietary Supplements
Status: Open

Summary

Adept Life Science, LLC received a warning letter for serious Current Good Manufacturing Practice (CGMP) violations in its dietary supplement manufacturing operations at its Chandler, Arizona facility, inspected in April 2022. The company failed to establish identity specifications for raw materials used in its dietary supplement products and did not meet CGMP requirements for manufacturing, packaging, labeling, and holding operations, rendering the products adulterated under federal law. Additionally, certain dietary supplement product lines were found to be misbranded in violation of FDA regulations. The company's responses to FDA's initial inspection observations were incomplete, failing to adequately address all cited violations.

Adept Life Science, LLC FDA Warning Letter, January 24, 2023