Robert P. Nickell
CEO
Nubratori, Inc. dba Nubratori Rx
381 Van Ness Avenue, Suite 1507
Torrance , CA 90501-7220
United StatesFEI 3010166491Issued Jan 22, 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 3010166491.
Violations7
Issue DateJan 22, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Nubratori, Inc. dba Nubratori Rx
Location
Robert P. Nickell
CEO
Nubratori, Inc. dba Nubratori Rx
381 Van Ness Avenue, Suite 1507
Torrance , CA 90501-7220
United States
FEI Number
3010166491
Country
United States
Issue Date
January 22, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Nubratori, Inc. dba Nubratori Rx, a registered outsourcing facility for compounding sterile drugs, was cited for serious deficiencies in drug manufacturing practices that put patients at risk. During a July 2024 FDA inspection, investigators identified violations of current good manufacturing practices and other applicable provisions of the Federal Food, Drug, and Cosmetic Act, resulting in the production of adulterated drug products. The company received a Form FDA 483 and submitted responses in August and October 2024, but the deficiencies were deemed sufficiently serious to warrant a Warning Letter.
Nubratori, Inc. dba Nubratori Rx FDA Warning Letter, January 22, 2025
Talk to a Specialist