Synovo Production, 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 document the dates and results of quality system reviews by management with executive responsibility as required by 21 CFR 820.20(c). Specifically, your firm could not provide evidence that it conducted management reviews since its inception in April 2020. You did not follow your Management Review SOP2-011, Rev. D which states that at least once a year top management will meet to review the suitability and effectiveness of the quality system.

Passage 2

Failure to conduct quality audits as required by 21 CFR 820.22. Specifically, your firm could not provide evidence that an annual audit had occurred in 2021. You did not follow your Internal Audit SOP2-024, Rev. D which states that each quality system element listed on the audit schedule will be audited at a minimum of once per year.

Passage 3

Failure to document personnel training as required by 820.25(b). Specifically, your firm could not provide training records for your Regulatory Affairs (RA) Manager. You did not follow your Training and Personnel Qualification SOP2-018, Rev. D which states that a training record form (SOP-018-91) and electronic documentation of training shall be completed. The RA Manager also stated that your firm does not have training records for your firm’s other employees.