Drug factory · FDA FEI 3006271438

Novel Laboratories, Inc.

400 Campus Drive, Somerset, 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.

Apr 17, 2026 inspection

• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy and 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.
• 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.
• Representative Samples Criteria 21 CFR 211.84(b)
  The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria.

Nov 8, 2018 inspection

• Late submission of annual safety reports 21 CFR 314.80(c)(2)
  Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
• Late submission of quarterly safety reports 21 CFR 314.80(c)(2)
  Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.
• Timely submission 21 CFR 314.81(b)(2)
  An annual report was not submitted within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.

Feb 23, 2018 inspection

• Expiration date lacking 21 CFR 211.137(a)
  Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
• 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.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The control systems necessary to prevent contamination or mix-ups are deficient.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

Aug 26, 2013 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established specifications are not rejected.
• Written procedures followed 21 CFR 211.186(a)
  Procedures for the preparation of master production and control records are not described in a written procedure and followed.
• 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.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into the failure of a batch or any of its components to meet specifications.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
• Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
  Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
• Written record of complaint to include findings, follow-up 21 CFR 211.198(b)(2)
  Written records of investigation of a drug complaint do not include the follow-up.
• 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--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in current good manufacturing practices.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.

Registered with FDA for: analysis; manufacture; pack.