Mr. Glen S. Putnam
Senior Director of Global Quality
Rhyz Analytical Labs
75 West Center St.
Provo , UT 84601-4432
United StatesFEI 3020181366Issued Nov 12, 2025Center for Drug Evaluation and Research (CDER)
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 3020181366.
Violations2
Issue DateNov 12, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Rhyz Analytical Labs
Location
Mr. Glen S. Putnam
Senior Director of Global Quality
Rhyz Analytical Labs
75 West Center St.
Provo , UT 84601-4432
United States
FEI Number
3020181366
Country
United States
Issue Date
November 12, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Rhyz Analytical Labs, a contract testing laboratory, received a warning for adulterated drug products due to Current Good Manufacturing Practice (CGMP) violations in its testing operations. FDA inspectors found that the company failed to thoroughly investigate unexplained discrepancies and microbiological test failures, instead repeatedly accepting inadequate root cause analyses attributed to "unknown laboratory error" and relying on retest data without sufficient scientific justification. The facility conducted chemical and microbiological testing of over-the-counter drug products for customers but lacked proper corrective and preventive action procedures to address contamination events and ensure product safety.
Rhyz Analytical Labs FDA Warning Letter, November 12, 2025