Azurity Pharmaceuticals, Inc.
Overview
Azurity Pharmaceuticals, Inc. is a private pharmaceutical company focused on providing innovative, high-quality medications in the areas of unmet needs, particularly for patients requiring unique formulations and dosing options. Azurity specializes in developing and commercializing products primarily for the U.S. market.
Therapeutic areas
FDA compliance signals
8 FDA enforcement records linked to this company.
- warning_letter2024-09-20
FDA Warning Letter (drug product)
- recall — Class I2024-02-07
Labeling: Label Mix-up
- recall — Class III2024-01-10
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
- recall — Class II2023-04-12
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
- 4832022-02-24
Cleaning SOPs/equipment protection
- 4832022-02-24
Top/Middle/Bottom container sampling
- 4832022-02-24
Cleaning / Sanitizing / Maintenance
- recall — Class I2021-10-13
Product Mix-up: Incorrect diluent component included in the kit.
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