INCELL CORP LLC
Overview
INCELL CORP LLC is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering EZ-CPZ(TM) AND EZ-CPZ-H(TM) CELL CRYOPRESERVATION MEDIA; M3(TM) CELL CULTURE MEDIA; ZAPR RED BLOOD CELL LYSING BUFFER; ZSOL:F, ZSOL:M AND ZSOL:MH BIOPROCESSING BUFFER FAMILY; ZTM: A1 AND ZTM: A2 DEFINED CULTURE MEDIA.
API / Drug Master Files
INCELL CORP LLC holds 5 active (6 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- ZAPR RED BLOOD CELL LYSING BUFFERActive2012-09-21
- ZTM: A1 AND ZTM: A2 DEFINED CULTURE MEDIAActive2012-07-26
- ZSOL:F, ZSOL:M AND ZSOL:MH BIOPROCESSING BUFFER FAMILYActive2012-04-12
- EZ-CPZ(TM) AND EZ-CPZ-H(TM) CELL CRYOPRESERVATION MEDIAActive2005-08-15
- M3(TM) CELL CULTURE MEDIAActive2004-05-24
- ACE(TM) CELL CULTURE MEDIUMInactive2005-08-15
FDA compliance signals
9 FDA enforcement records linked to this company.
- 4832023-09-29
Procedures for sterile drug products
- 4832023-09-29
Expiration date lacking
- 4832023-09-29
Procedures not in writing, fully followed
- 4832023-09-29
Testing and release for distribution
- warning_letter2016-10-28
FDA Warning Letter (drug product)
- 4832015-09-01
Container label, outsourcer facility
- 4832015-09-01
Procedures for sterile drug products
- 4832015-09-01
Environmental Monitoring System
- 4832015-09-01
Cleaning System
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