Drug factory · FDA FEI 3005263655

Amneal Pharmaceuticals of New York, LLC

50 Horseblock Rd, Brookhaven, 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.

May 24, 2017 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Cleaning SOPs/equipment protection 21 CFR 211.67(b)(5)
  Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.

Jul 3, 2013 inspection

• Establishment of time limitations 21 CFR 211.111
  Time limits are not established when appropriate for the completion of each production phase to assure the quality of the 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 in writing.
• 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.

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