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FDA establishment 3010165406, Argenteuil, France. Part of Multaler et Cie SAS's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 1
Last inspection ended: Apr 17, 2024
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.84(d)(1). Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.165(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
21 CFR 211.186(b)(8). Description of containers, labels, et. al. Master production and control records lack a specimen or copy of each label and all other labeling.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.111. Establishment of time limitations Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
Official Action Indicated (OAI)
Sep 22, 2017
Drugs · Drug Quality Assurance
11 cited references
21 CFR 211.160(b)(1). Samples (various types) representative, identified properly Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of components and drug product containers are not representative and adequately identified.
21 CFR 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not followed.
21 CFR 211.125(f). Procedures Written and Followed Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written.
21 CFR 211.194(a)(2). Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use.
21 CFR 211.68(b). Computer control of master formula records 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.
21 CFR 211.188(b). Batch production and Batch Control Record Requirements The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not documented at the time of performance.
21 CFR 211.160(b)(4). Calibration - at intervals, written program, remedial action The calibration of instruments is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met.
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Argenteuil, France. Part of