FDA 483 - Dallas Metro Food inc. - February 09, 2024

An FDA inspection of A&Z Pharmaceutical, Inc. in Hauppauge, NY, conducted from December 11, 2023, to February 9, 2024, resulted in the issuance of a Form 483, detailing several significant observations related to both medical device and Over-the-Counter (OTC) drug manufacturing.

For medical device operations, the firm exhibited inadequate procedures for complaint handling, failing to evaluate complaints for potential Medical Device Reporting requirements. Design validation for devices like thermometer strips and digital thermometers was not performed under actual or simulated use conditions. Additionally, supplier management procedures were deficient, lacking comprehensive evaluations for quality requirements and quality agreements with contract manufacturers. The quality system further showed weaknesses in internal audit procedures, with no audits conducted since at least 2019, and management reviews, which had also not occurred since 2019 and lacked defined data inputs. These observations indicate non-compliance with 21 CFR Part 820 for medical devices.

Regarding OTC drug manufacturing, the firm lacked established procedures for the rework of drug products, as demonstrated by the undocumented re-inspection and release of a rejected batch of First Aid/Burn Cream. Furthermore, the stability program for OTC drug products was found to be inadequate, specifically omitting microbial limit testing at any stability timepoint, contrary to 21 CFR Part 211.

A&Z Pharmaceutical, Inc. is required to address these observations by implementing robust corrective and preventive actions to ensure compliance with federal regulations for both medical devices and drug products.