Edge Biologicals Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures, as required by 820.75(a). For example:

Passage 2

Failure to adequately establish procedures for corrective and preventative actions, as required by 820.100(a). For example,

Passage 3

Failure to adequately establish procedures and maintain requirements that must be met by suppliers, contractors, and consultants, as required by 820.50(a). For example, your firm purchases components and services critical to product quality; however, you failed to evaluate suppliers on their abilities to meet specific requirements.

Passage 4

Failure to maintain a device master record, as required by 21 CFR 820.181. For example, your firm failed to demonstrate that the Mueller Hinton Agar was manufactured according to the Device Master Record (DMR). Your quality manager could not locate the DMR to ensure the device production record (DHR) for each batch or lot of the Mueller Hinton Agar met specifications, including specifications for manufacturing, label requirements, and testing.

Passage 5

Failure to establish procedures for acceptance activities, as required by 21 CFR 820.80(a). You did not ensure that product is controlled until required acceptance activities have been completed and final release is authorized. In-process, nonconforming, and released IVD products were observed throughout production and storage areas without any indication of acceptance status. For example, testing media (**(b)(4)**) was observed stored in the employee breakroom refrigerator with food items.

Passage 6

Failure to conduct quality audits to determine whether the quality system activities and results comply with quality system procedures, as required by 21 CFR 820.22. From 2013 to 2019 your firm failed to conduct quality audits as required per QMS-003/L, Quality System Internal Audit Program.

Passage 7

Failure to ensure that personnel have necessary training and experience to perform their jobs, as required by 21 CFR 820.25(a). You failed to document adequate training as required by your procedure MAN-005/I, EBI Employee Training. Five out of **(b)(4)** production employees have no documented training records and no annual training on the quality system regulations has been documented for any employee.