FLEMING LABORATORIES LTD
Overview
FLEMING LABORATORIES LTD is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering HYDROXYZINE HYDROCHLORIDE USP.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances FLEMING LABORATORIES LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
FLEMING LABORATORIES LTD holds 1 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.
- HYDROXYZINE HYDROCHLORIDE USPActive2023-08-10
- ETODOLAC USPInactive2017-11-11
- CARISOPRODOL USPInactive2017-08-09
- CYCLOBENZAPRINE HYDROCHLORIDE USP BULKInactive2009-08-19
- MECLIZINE HCL USPInactive2007-04-23
- CARISOPRODOL USPInactive2006-09-26
FDA compliance signals
19 FDA enforcement records linked to this company.
- warning_letter2018-02-14
FDA Warning Letter (drug product)
- 4832017-03-17
Approve or reject procedures or specs
- 4832017-03-17
Scientifically sound laboratory controls
- 4832017-03-17
Storage off Floor, Spaced Suitably
- 4832017-03-17
Establish reliability of supplier's C of A
- 4832017-03-17
Handling and Storage to Prevent Contamination
- 4832017-03-17
Written program not followed
- 4832017-03-17
Actual yield, % of theoretical yield
- 4832017-03-17
Reporting of adverse drug experience to FDA
- 4832017-03-17
Calibration - at intervals, written program, remedial action
- 4832017-03-17
Microbiological testing
- 4832017-03-17
Procedures not in writing, fully followed
- 4832017-03-17
Establishment of time limitations
- 4832017-03-17
Written procedures not established/followed
- 4832017-03-17
Records reviewed annually
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