Drug factory · FDA FEI 3007250542

Cenexi

52 rue Marcel et Jacques Gaucher, Fontenay-sous-Bois, France

What it does, for whom

FDA inspection history

What inspectors wrote down

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

Apr 28, 2015 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not documented at the time of performance.
• Batches Formulated to less than 100% 21 CFR 211.101(a)
  Written production and control procedures include batches formulated with the intent to provide less than 100 percent of the labeled or established amount of active ingredient.
• 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 and followed.
• 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.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Protective Apparel Not Worn 21 CFR 211.28(a)
  Protective apparel is not worn as necessary to protect drug products from contamination.
• Cleaning System 21 CFR 211.42(c)(10)(v)
  Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
• Written sanitation procedures not followed 21 CFR 211.56(b)
  Written procedures for sanitation are not followed.

Dec 11, 2012 inspection

• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include meaningful test methods.
• Sterility/pyrogen-free testing 21 CFR 211.167(a)
  Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into unexplained discrepancies.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
• Written calibration / inspection records not kept 21 CFR 211.68(a)
  Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.

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