Auro Pharmacies, Inc DBA Central Drugs – FDA 483, Jun 29, 2017

From June 13-29, 2017, the FDA inspected Auro Pharmacies Inc., an outsourcing facility located at 511 S Harbor Blvd Ste F, La Habra, CA. The inspection revealed 13 observations regarding the firm's compliance with manufacturing regulations for sterile drug products.

Key violations include the quality control unit's failure to ensure products meet specifications and operations follow SOPs. Examples include releasing Methylcobalamin 1 mg/mL injection lots (170214@1, 170310@1) that failed assay tests, approving DMSO 99.9% Infusion lots (170210@1, 170322@2, 170504@2) without verifying sterilization, and approving batch records with unapproved forms or discrepancies between master formulations and actual practices.

Test methods for sterile drug product release were not validated or verified. Contract lab assay procedures were non-validated, and in-house tests for Methylcobalamin, sterility, endotoxin, and particulates lacked validation.

Personnel gowning was inappropriate for sterile filtration, with exposed skin and non-sterile goggles observed. Aseptic preparation procedures were deficient, including an operator touching a non-sterile surface during filling. Sterilization processes lacked adequate validation, with no active air viable count assessment during ISO 5 LFH certification, no active air monitoring during aseptic