Drug factory · FDA FEI 3002806390

Fareva Pau

Avenue du Bearn CS 10040, Idron, France

Problems found, fixed voluntarily at FDA's last inspection, Jan 17, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

10 drug inspections on record since 2009: 2 with no problems, 6 with problems fixed voluntarily, 2 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Leuprolide	Makes it and tests it	Accord BioPharma Inc., Foresee Pharmaceuticals Co., Ltd.	69448-014, 69448-023, 72851-100

Ended	Result	Program	Problems noted
Jan 17, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 5, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 27, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 13, 2017	No problems found	Drug Quality Assurance	—
Jun 10, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	3
Feb 26, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	6
May 12, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 12, 2011	No problems found	Drug Quality Assurance	—
Sep 8, 2009	Serious problems, FDA action	Drug Quality Assurance	—
Sep 8, 2009	Serious problems, FDA action	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Aseptic Processing Area 21 CFR 211.42(c)(10)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not justified.
Verification of component addition 21 CFR 211.101(d)
Each component is not added to the batch by one person and verified by a second person..
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
Equipment construction - reactive surfaces 21 CFR 211.65(a)
Equipment surfaces that contact in-process materials and drug products are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the storage and rejection of components.

Registered with FDA for: analysis; label; manufacture; pack; sterilize.