Drug factory · FDA FEI 3001549109

Lonza Tampa LLC

4901 W Grace Street, Tampa, FL, 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.

Aug 22, 2025 inspection

• In-process materials characteristics testing 21 CFR 211.110(c)
  In-process materials are not tested for identity, strength, quality and purity and approved or rejected by the quality control unit during the production process and after storage for long periods.
• In-process materials characteristics testing 21 CFR 211.110(c)
  In-process materials are not tested for identity, strength, quality and purity and approved or rejected by the quality control unit during the production process and after storage for long periods.
• In-process materials characteristics testing 21 CFR 211.110(c)
  In-process materials are not tested for identity, strength, quality and purity and approved or rejected by the quality control unit during the production process and after storage for long periods.
• In-process materials characteristics testing 21 CFR 211.110(c)
  In-process materials are not tested for identity, strength, quality and purity and approved or rejected by the quality control unit during the production process and after storage for long periods.
• 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, written and followed.
• 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, written and followed.
• 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, written and followed.
• 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, written and followed.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• 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.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure, micro-organisms, dust, humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure, micro-organisms, dust, humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure, micro-organisms, dust, humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure, micro-organisms, dust, humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Cleaning SOP/responsibility 21 CFR 211.67(b)(1)
  Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment.
• Cleaning SOP/responsibility 21 CFR 211.67(b)(1)
  Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment.
• Cleaning SOP/responsibility 21 CFR 211.67(b)(1)
  Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment.
• Cleaning SOP/responsibility 21 CFR 211.67(b)(1)
  Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the maintenance, cleaning, sanitizing and inspection of equipment.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the maintenance, cleaning, sanitizing and inspection of equipment.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the maintenance, cleaning, sanitizing and inspection of equipment.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the maintenance, cleaning, sanitizing and inspection of equipment.
• 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.
• 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.
• 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.
• 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.

Sep 29, 2023 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.
• 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.

Registered with FDA for: label; pack.