# FDA EIR - TTY Biopharm Company Ltd. - August 22, 2022

Source: https://www.keypedia.com/records/eir/tty-biopharm-company-ltd/f6067e9f-1b19-4825-8771-c1358f26c823

> FDA EIR for TTY Biopharm Company Ltd. on August 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: TTY Biopharm Company Ltd.
- Inspection Date: 2022-08-22
- Product Type: drugs
- Summary: A pre-approval inspection of TTY Biopharm Company Limited Lioudu Factory was conducted by the Food and Drug Administration from August 22 to August 30, 2022. This inspection, carried out under Compliance Program 7346.832 for Pre-Approval Inspections, focused on the company's readiness for commercial manufacturing, conformance to application, and data integrity for its Amphotericin B Liposomes for Injection, ANDA 214010. At the conclusion of the inspection, a four-item FDA Form 483, "Inspectional Observations," was issued to the Senior Director of Production & Operation. The main observations included deficiencies such as the failure to maintain reserve samples for submitted batches, incomplete retrieval of environmental monitoring contact plates, lack of comprehensive training for personnel on current Good Manufacturing Practice (CGMP) regulations (specifically 21 CFR 211), and the absence of hot water in designated handwashing areas within Class C and D facilities, as well as toilet facilities. Despite these observations, the inspection was classified as Voluntary Action Indicated (VAI), and approval for the Amphotericin B Liposomes for Injection application is being recommended. TTY Biopharm Company Limited has stated its intention to provide a written response to the FDA Form 483, outlining its corrective actions.

## Related Officers

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Company: https://www.keypedia.com/companies/tty-biopharm-company-ltd/4efb861f-8aaa-42c6-9ae6-ae2c077d2d6e