Quarterly Report QSR-24Q2

special_reports

Highlights issues related to deficiencies in audits.

Facility Inspection List from 10/2023 – 12/2023

special_reports

A summary of FDA inspections that were conducted between October 2023 and December 2023. The report included whether or not the facility received a 483, the length of the inspection, and CFR citations where available.

Quarterly Special Report QSR – 24Q1

special_reports

Highlights issues related to deficiencies in training.

Facility Inspection List from 7/2023 – 9/2023

special_reports

A summary of FDA inspections that were conducted between July 2023 and September 2023. The report includes whether or not a facility received a 483, length of inspection and CFR citation where available.

Quarterly Report QSR-23Q4

special_reports

Highlights issues related to deficiencies in investigations, Quality Control Unit, procedures, and laboratory controls.

Facility Inspection List from 04/2023 to 06/2023

special_reports

A summary of FDA inspections that were conducted between April 2023 and June 2023. The report includes whether or not a facility received a 483, length of inspection and CFR citation where available.

Quarterly Report QSR-23Q3

special_reports

Highlights issues related to deficiencies in CAPA. complaints, validations and purchasing.

Facility Inspection List from 1/2023 – 3/2023

special_reports

A summary of FA inspections that were conducted between January 2023 and March 2023. The report includes whether or not a facility received a 483, length of inspection and CFR citation where available.

Quarterly Report QSR-23Q2

special_reports

Highlights issue related to deficiencies in equipment, computer controls, cleaning and testing.

Facility Inspection List from 10/2022 – 12/2022

special_reports

A summary of FDA inspections that were conducted between October 2022 and December 2022. The report includes whether or not a facility received a 483, length of inspection and CFR citations where available.