Drug factory · FDA FEI 2431950

Jerome Stevens Pharmaceuticals, Inc.

60 DaVinci Drive, Bohemia, 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.

Jun 15, 2022 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Component release checked by 2nd person 21 CFR 211.101(d)
  Each container of component dispensed to manufacturing is not examined by a second person to assure that the weight or measure is correct as stated in the batch records.
• In-process materials characteristics testing 21 CFR 211.110(c)
  In-process materials are not tested for and approved or rejected by the quality control unit.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of so that their identity, strength, quality, and purity are not affected.
• Laboratory Test Method Verification 21 CFR 211.194(a)(2)
  Verification of the suitability of the testing methods is deficient in that they are not documented on the laboratory records.
• 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.
• 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.

Apr 11, 2019 inspection

• 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.
• Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
  Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
• 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.
• Incomplete periodic safety report 21 CFR 314.80(c)(2)(ii)(A)
  You failed to submit a periodic report containing an analysis of the post marketing 15-day Alert reports submitted during the reporting interval and a history of actions taken since the last report because of adverse drug experiences.

Mar 30, 2017 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and written.
• Strict control not exercised over labeling issued 21 CFR 211.125(a)
  Strict control is not exercised over labeling issued for use in drug product labeling operations.
• Written records kept in individual logs 21 CFR 211.182
  Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
• 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.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

Jul 23, 2015 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not justified.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• Deviations of production time limits 21 CFR 211.111
  Deviations from production time limits are not justified.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• 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.
• Clothing appropriate for duties performed 21 CFR 211.28(a)
  Clothing of personnel engaged in the manufacturing of drug products is not appropriate for the duties they perform.

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