EIR

Release date- 26072019 - Mumbai - Indoco Remedies announced today that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for their sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa.

Upon conclusion of the Establishment Inspection Report, zero FDA-483's were issued.

After Immunomedics disclosed last night that it has received an Establishment Inspection Report, or EIR, from the FDA, Goldman Sachs analyst Paul Choi said that management indicated the report identified no additional issues compared to the original Form 483 and Complete Response Letter previously issued, but did include details they expect to be helpful in addressing FDA concerns.

Food establishment inspection report. Retrieved from http://ehs.ncpublichealth.com/docs/forms/FoodInspectionForm-Mar13.pdf

has received correspondence from the FDA indicating closure of the establishment inspection report from March 2018, the company said.

The company said that the company has received an Establishment Inspection Report (EIR) from the US drug regulator as closure of audit for the Bachupally, Hyderabad facility.

Multiple QSDs can be registered simultaneously; companies registering for a QSD must provide certifications (ISO 13485 or ISO 13488) and quality system documents (quality manual and quality procedures), or a Certificate to Foreign Government and Establishment Inspection Report or an audit report with the Free Sale Certificate.

* "Critical" items on the Tennessee Department of Health food service establishment inspection report (a)

The FDA issued an Establishment Inspection Report to Daewoong Pharmaceutical confirming the favorable completion of its pre-approval inspection of Daewoong's manufacturing facility in South Korea which was purpose built for production of DWP-450.

FDA inspection, with no FDA-483 issued, as per the EIR (Establishment Inspection Report) received from the Center for Food Safety and Applied Nutrition of the FDA.