Drug factory · FDA FEI 1000171152

Astrea Monts

18 Rue de Montbazon, Monts, France

Serious problems, FDA action at FDA's last inspection, Oct 18, 2022.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

4 drug inspections on record since 2013: 0 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Gadolinium Cation (3+)	Makes it, tests it, packages it and labels it	Guerbet LLC	67684-2000
Iodine	Makes it and packages it	Guerbet LLC	67684-1901
Verapamil	Makes it	Areva Pharmaceuticals, Inc.	59923-605, 59923-606

FDA inspection history

Ended	Result	Program	Problems noted
Oct 18, 2022	Serious problems, FDA action	Drug Quality Assurance	10
Mar 29, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 9, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	3
Feb 26, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—

What inspectors wrote down

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

Oct 18, 2022 inspection

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 established, written and followed.
Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not documented at the time of performance.
Valid stability test methods 21 CFR 211.166(a)(3)
The written stability program for drug products does not include reliable, meaningful and specific test methods.
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.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Temperature / Humidity Controls 21 CFR 211.42(c)(10)(ii)
Aseptic processing areas are deficient regarding humidity controls.
Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions.
Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Jun 9, 2015 inspection

Microbiological testing 21 CFR 211.165(b)
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
There was a failure to handle and store components and drug product containers at all times in a manner to prevent contamination.

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