Drug factory · FDA FEI 2246315

Patheon Manufacturing Services LLC

1125 Pleasantview Ter, Ridgefield, NJ, United States

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 18, 2024 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 and followed.

Jan 21, 2014 inspection

• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.

Jun 21, 2011 inspection

• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch.
• Rejecting When Specifications Not Met 21 CFR 211.84(e)
  Failure to reject any lot of drug product containers that did not meet the appropriate written specifications for identity, strength, quality, and purity.

Dec 21, 2010 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 and written.
• Components complete listing 21 CFR 211.186(b)(3)
  The master production and control records do not include a complete list of components designated by names or codes sufficiently specific to indicate any special quality characteristics.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy 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.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the processing of a drug product lack the training required to perform their assigned functions.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The control systems necessary to prevent contamination or mix-ups are deficient.
• Exhaust systems inadequate to control air contamination 21 CFR 211.46(c)
  Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine inspection and checking of automatic equipment is not performed according to a written program designed to assure proper performance.
• input/output verification 21 CFR 211.68(b)
  Input to and output from records or data are not checked for accuracy.
• Written Procedures Not Followed 21 CFR 211.80(a)
  Written procedures are not followed for the receipt and identification of components.
• 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 significant chemical, physical, or other change or deterioration in a distributed drug product.

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