FDA 483 at Bloomington crimp vials

DURING AN INSPECTION OF YOUR FIRM (I) (WE) OBSERVED: date 02/24/2020; and A-SOP-21-01-042, "Aseptic Interventions in the Vial and ,__ ______, ' rev. 35,.

Catalent hit with FDA 483 at Bloomington plant

Sep 22, 2022 A US FDA Form 483 has revealed visible foreign particles in certain batches of drug product at Catalent's Bloomington, Indiana facility.

Catalent's Covid-19 vaccine manufacturing site hit with Form 483

Catalent's Covid-19 vaccine manufacturing site hit with Form 483 over foreign objects in vials and other QC issues. Tyler Patchen. News Reporter. An Indiana-

January 30, 2022 Summary Basis for Regulatory Action - SPIKEVAX

Jan 30, 2022 ORA/OBPO performed a surveillance inspection of the Baxter facility in Bloomington, IN in. November 2021. A Form FDA 483 was issued at the ...

Warning Letters | FDA

Main FDA Warning Letter Page.

Ben Venue Laboratories, Inc. 483 inspection 11/7/11 - FDA

Dec 2, 2011 FORM FDA 483 (9/01()} PREVIOUS EDinON OBSOLETE. INSPECTIONAL OBSERVATIONS. Page 5 of 11 b. Discarding the media filled vials precludes the ...

The most significant FDA citations of 2021-2022 - Fierce Pharma

The Irvine plant's shortfalls, which yielded a Form 483, according to Reuters, have been linked to the recall of 2.5 million vials of Teva meds used to

Warning Letter - SEC.gov

Apr 1, 2015 Exception report record, PR ID 119409, noted that the manual vial ... and you also rejected 250 vials during the crimping process without ...

Baxter Gets Form 483 for Observations of Recurring Vermin, Lack of

Mar 22, 2022 Baxter Pharmaceuticals Solutions' contract manufacturing facility in Bloomington, Ind., has received a Form 483 for several deficiencies ...