Tag: Sterile process controls

USFDA 483 to Pharmathen Flags Deficient

USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form

USFDA 483 to Catalent Baltimore Flags De

An USFDA 483 to CDMO major Catalent’s Baltimore facility (FEI 3015558590) in US cite poor

FDA 483 to Favera, France Cites Gaps in

FDA has published the USFDA Form 483 issued to sterile drug manufacturing facility of Fareva

OAI Classification for Sun Pharma Halol

In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official

Janssen’s Korea Vaccine Unit USFDA 483

Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical

USFDA Untitled Letter To Nectar Cites De

Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies

USFDA 483 to Catalent Indiana Cites Poor

Catalent USFDA 483 /Bloomington (FEI :3005949964)/ Inspection Dates: May 4-12, 2023 / Inspectors: Wayne Scifert,