Drug factory · FDA FEI 1021343

Hospira, Inc.

Highway 301 North, Rocky Mount, NC, 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.

Nov 21, 2019 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into do not always include the conclusions and follow-up.

Feb 2, 2018 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not justified.
• Test devices not meeting specifications 21 CFR 211.160(b)(4)
  Test devices are deficient in that apparatus not meeting established specifications are used.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine inspection of mechanical equipment is not performed according to a written program designed to assure proper performance.
• Documentation 21 CFR 820.100(b)
  Corrective and preventive action activities and/or results have not been adequately documented.

Mar 1, 2013 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.
• 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.
• Rejected in-process materials not quarantined 21 CFR 211.110(d)
  Rejected in-process materials are not identified and controlled under a quarantine system to prevent their use in manufacturing or processing operations for which they are unsuitable.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
• Sampling and testing procedures described 21 CFR 211.160(b)(1)
  Written specifications for laboratory controls do not include a description of the testing procedures used.
• Testing and release for distribution 21 CFR 211.165(a)
  Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and 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.
• Quality control unit review of records 21 CFR 211.192
  Drug product production and control records, are not approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
• 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.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
• Temperature / Humidity Controls 21 CFR 211.42(c)(10)(ii)
  Aseptic processing areas are deficient regarding humidity controls.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Cleaning System 21 CFR 211.42(c)(10)(v)
  Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure, humidity, and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
• 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.
• 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.

Aug 4, 2011 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• 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: analysis; label; manufacture; pack.