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FDA establishment 3000234005, Poce Sur Cisse, France. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 6
Official action indicated: 1
Last inspection ended: Sep 16, 2025
Warning letters: 0
Import refusals since 2024: 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 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
21 CFR 211.186(a). Written procedures followed Procedures for the preparation of master production and control records are not described in a written procedure.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
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. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Official Action Indicated (OAI)
Dec 13, 2018
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
May 16, 2017
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Mar 18, 2014
Drugs · Drug Quality Assurance
9 cited references
21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include assignment of responsibility and description in sufficient detail of methods, equipment and materials used.
21 CFR 211.84(d)(6). Microbiological Contamination Exam Each lot of a closure that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.
21 CFR 211.110(a). Control procedures fail to include the following Control procedures fail to include clarity, completeness or pH of solutions.
21 CFR 211.198(b)(3). Determination not to conduct investigation of complaint The written record did not include the reason an investigation was found not to be necessary when an investigation into the failure of a batch or any of its components to meet specifications was not conducted.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.
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 and the signatures and dates entered by the person or persons responsible for the approval of labeling.
21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established standards and quality control criteria are not rejected.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Voluntary Action Indicated (VAI)
Sep 20, 2011
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established standards and quality control criteria are not rejected.
21 CFR 211.110(b). In-process materials specifications In-process specifications are not consistent with drug product final specifications and determined by the application of suitable statistical procedures where appropriate.
21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
Voluntary Action Indicated (VAI)
Apr 29, 2010
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Import Refusals
1 refused shipment lines since 2024, grouped by product and charges
Product
Charges
Latest
AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)Drugs · 62OCA14
Maker not registered with FDADrug or device not listed with FDAUnapproved new drug
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
Poce Sur Cisse, France. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.