Drug factory · FDA FEI 1000521505

A&Z Pharmaceutical, Inc.

350 Wireless Blvd., Hauppauge, 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.

Sep 26, 2025 inspection

• 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.
• 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.

Nov 22, 2017 inspection

• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not established and followed.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not established and followed.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review 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.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review 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.
• Salvaging and return to marketplace 21 CFR 211.208
  Drug products that have been subjected to improper storage conditions were salvaged and returned to the marketplace without further evidence or inspection.
• Salvaging and return to marketplace 21 CFR 211.208
  Drug products that have been subjected to improper storage conditions were salvaged and returned to the marketplace without further evidence or inspection.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration and checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration and checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.

Mar 31, 2015 inspection

• 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.
• 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.

Jun 3, 2014 inspection

• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not followed.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not followed.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
• 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 construction and location to facilitate cleaning, maintenance, and proper operations.
• 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 construction and location to facilitate cleaning, maintenance, and proper operations.
• Adequate space lacking to prevent mix-ups and contamination 21 CFR 211.42(b)
  The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, in-process materials, and drug products and to prevent contamination.
• Adequate space lacking to prevent mix-ups and contamination 21 CFR 211.42(b)
  The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, in-process materials, and drug products and to prevent contamination.
• Air filtration system lacking in production area 21 CFR 211.46(c)
  The production area air supply lacks an appropriate air filtration system.
• Air filtration system lacking in production area 21 CFR 211.46(c)
  The production area air supply lacks an appropriate air filtration system.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.

Registered with FDA for: analysis; manufacture; pack.