Drug factory · FDA FEI 3002807336

Janssen Pharmaceutica NV

Turnhoutseweg 30, Beerse, Belgium

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.

Mar 1, 2016 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.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  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.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review whether or not the batch has been already distributed.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning in a distributed drug product.

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