Outsourcing facilities Archives - Lachman Consultant Services, Inc.

Outsourcing Facility Fee Rates for Fiscal Year 2023 Announced!

By Bob Pollock Jul 27, 2022 FDA Outsourcing facilities Regulatory Affairs User Fees

Outsourcing facilties are compounding facilities that are registered by the FDA and subject to inspection. The fee structure is rather simple, with facility fees and reinspection fees only. The fee rates for FY 2023 will go into effect on October 1, 2022. A chart comparing the FY 2022 and FY 2023 fees is provided below: FY 2022 […]

Apr

Close-up medical syringe with a vaccine.

Compounders of Sterile Products Remain on FDA’s Radar

By Bob Pollock Apr 05, 2022 Compliance Outsourcing Outsourcing facilities Sterile products

In the past six (6) months, FDA has issued two (2) Alerts (here and here), for patients and caregivers to not use sterile products manufactured by the two companies cited in the alerts. One company compounds product for human patients, and the other for veterinarians and animals (pet owners, beware). In that same 6-month period, […]

Outsourcing facilities

Outsourcing Facility Fee Rates for Fiscal Year 2023 Announced!

Compounders of Sterile Products Remain on FDA’s Radar

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