Drug factory · FDA FEI 1216032

Citra Labs, LLC

55 Messina Drive, Braintree, MA, 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 27, 2017 inspection

• Written records kept in individual logs 21 CFR 211.182
  Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
• Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
  The master production and control records are deficient in that they do not include complete manufacturing, control, instructions and specifications.
• 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.
• 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.

Jun 13, 2014 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that 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 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.
• 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 size, construction, and location to facilitate cleaning, maintenance, and proper operations.
• Components withheld from use pending release 21 CFR 211.84(a)
  Each lot of components and drug product containers is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.

Oct 30, 2009 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.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• 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 in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• Test methods 21 CFR 211.165(e)
  The sensitivity and reproducibility of test methods have not been established and documented.
• In-Process and Laboratory Control Results 21 CFR 211.188(b)(5)
  The batch production and control records are deficient in that they do not include in-process control results.
• 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.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture and processing of a drug product lack the education, training, and experience required to perform their assigned functions.
• Product flow through building is inadequate 21 CFR 211.42(b)
  The flow of components, drug product containers, and closures though the building is not designed to prevent contamination.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure and dust 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 packing and holding 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 contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine inspection and checking of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
• Written calibration / inspection records not kept 21 CFR 211.68(a)
  Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the testing, approval, and rejection of closures.
• Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
  There was a failure to handle and store components, drug product containers, and closures at all times in a manner to prevent contamination.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of components for testing or examination.
• Containers & Closures Clean, Sterilized, Pyrogen-free 21 CFR 211.94(c)
  Drug product closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

Registered with FDA for: manufacture.