Drug factory · FDA FEI 3006900385

Alk-Abello, Inc.

10 Farmington Valley Drive, Plainville, CT, 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.

Jun 13, 2025 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 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 did not include adequate validation of the aseptic and sterilization process.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established test procedures are not followed.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include reliable, meaningful and specific test methods.
• 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.
• 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.
• 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.
• 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.
• 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.

Oct 21, 2022 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 established and followed.
• 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 components, in-process materials and 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 any unexplained discrepancy whether or not the batch has been already distributed.
• Identification of Person Performing Review of Lab Records 21 CFR 211.194(a)(8)
  Laboratory records are deficient in that they do not include the signature of the second person reviewing the record for accuracy.
• 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.
• 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 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.
• Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
  There was a failure to handle and store components at all times in a manner to prevent contamination.
• Component identity verification 21 CFR 211.84(d)(1)
  Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
• Containers & Closures Clean, Sterilized, Pyrogen-free 21 CFR 211.94(c)
  Drug product containers were not clean to assure that they are suitable for their intended use.

May 3, 2021 inspection

• 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.
• Product flow through building is inadequate 21 CFR 211.42(b)
  The flow of components and drug products through the building is not designed to prevent contamination.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Mfg / Processing Operations Area 21 CFR 211.42(c)(5)
  Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
• Drains--Size, Back-siphonage Prevention 21 CFR 211.48(b)
  Drains are not provided with an air break or other mechanical device to prevent back-siphonage where connected directly with a sewer.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Sep 19, 2017 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 followed.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established standards and laboratory control mechanisms are not 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.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.

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