Drug factory · FDA FEI 3004483441

Cantrell Drug Company

Little Rock, Arkansas, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

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, 2018 inspection

• 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 to facilitate cleaning, maintenance, and proper operations.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over humidity is not provided when appropriate for 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.

Mar 22, 2018 inspection

• 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 followed.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
• Adverse Drug Experience 21 CFR 211.198(a)
  Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious and unexpected adverse drug experiences which are required to be reported to FDA.
• Component written specification 21 CFR 211.84(d)(2)
  Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

Jun 29, 2017 inspection

• 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 followed.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• 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.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to fully investigate errors that have occurred.
• 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.
• Air Supply 21 CFR 211.42(c)(10)(iii)
  Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
• 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.
• Drug product label, outsourcer facility FDCA 503B(a)(10)
  The labels of your outsourcing facility’s drug products are deficient.

Oct 14, 2016 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• 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.
• 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 identity and strength of each active ingredient prior to release.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Sterility/pyrogens - test methods written, followed 21 CFR 211.167(a)
  Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written and followed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• 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, labeling, in-process materials and drug products and to prevent contamination.
• Aseptic Processing Area 21 CFR 211.42(c)(10)
  Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
• Air Supply 21 CFR 211.42(c)(10)(iii)
  Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
• 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.
• Drug product label, outsourcer facility FDCA 503B(a)(10)
  The labels of your outsourcing facility’s drug products are deficient.