Drug factory · FDA FEI 3008897678

Chartwell Pharmaceuticals Congers, LLC.

77 Brenner Drive, Congers, NY, 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.

Nov 18, 2025 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.
• Identification of new containers 21 CFR 211.101(b)
  For components removed from the original containers, the new container fails to be identified with receiving or control number.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established test procedures and laboratory control mechanisms are not followed and documented at the time of performance.
• In-process sample representation/identification 21 CFR 211.160(b)(2)
  In-process samples are not properly identified.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not established and followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• Prepared for each batch, include complete information 21 CFR 211.188
  Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch.
• 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.
• Returned drug procedures in writing and followed 21 CFR 211.204
  Procedures describing the holding, testing and reprocessing of returned drug products are not 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.
• Habits of good sanitation & health 21 CFR 211.28(b)
  Production personnel were not practicing good sanitation and health habits.
• Penicillin processing area not kept separate 21 CFR 211.42(d)
  The operations relating to the manufacture, processing and packing of penicillin are not performed in facilities separate from those used for other drug products for human use.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Computer control of master formula records 21 CFR 211.68(b)
  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.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Apr 8, 2024 inspection

• Interval 21 CFR 314.80(c)(2)
  Periodic reports of non-alert adverse drug experiences have not been submitted yearly for an application which was approved three or more years ago.
• 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.

Sep 19, 2012 inspection

• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not followed.

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