Drug factory · FDA FEI 3007009553

Armstrong Pharmaceuticals, Inc.

25 John Road, Canton, MA, 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.

May 8, 2026 inspection

• 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.

Jun 14, 2012 inspection

• 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.
• 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.

Nov 13, 2009 inspection

• Instruments, apparatus, et. al. not meeting specs 21 CFR 211.160(b)(4)
  The use of instruments not meeting established specifications was observed.
• Acceptance/Rejection Levels 21 CFR 211.165(d)
  The statistical quality control criteria fail to include appropriate rejection levels.
• 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.
• Suitability of testing methods verified 21 CFR 211.194(a)(2)
  The suitability of all testing methods is not verified under actual conditions of use.
• 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Sep 29, 2009 inspection

• Description of containers, labels, et. al. 21 CFR 211.186(b)(8)
  Master production and control records lack a specimen or copy of each label and all other labeling and the signatures and dates entered by the person or persons responsible for the approval of labeling.
• 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 and written procedures required by current good manufacturing practice regulations.
• Failure to develop written procedures 21 CFR 314.80(b)
  Written procedures have not been developed for the surveillance, receipt, evaluation, and reporting to FDA of post marketing adverse drug experiences.
• Failure by applicant to report ADE 21 CFR 314.80(c)
  Adverse drug experience information has not been reported to FDA.
• 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.
• Mix-up 21 CFR 314.81(b)(1)(i)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be applied to another article.
• 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.
• Summary 21 CFR 314.81(b)(2)(i)
  An annual report did not include a brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product.

Registered with FDA for: analysis; distribute; label; manufacture; pack; particle size reduction.