Drug factory · FDA FEI 3027503130

Lohxa LLC

7 Pioneer Dr, North Oxford, 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.

Apr 30, 2025 inspection

• Microbiological testing 21 CFR 211.165(b)
  Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
• 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.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure, micro-organisms and dust is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• 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 maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Aug 3, 2023 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• In-process conformity - examination, sample testing 21 CFR 211.110(b)
  Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
• Accelerated stability studies 21 CFR 211.166(b)
  Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not supported with ongoing full shelf life studies.
• Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
  The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in processing and packing.
• 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.
• Complaint Record at Location of Investigation 21 CFR 211.198(b)(2)
  Complaint records are deficient in that they are not maintained at the establishment where the investigation occurred.
• 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.

Jul 19, 2021 inspection

• 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.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products.
• Labeling Control Records and Label Copies 21 CFR 211.188(b)(8)
  The batch production and control records are deficient in that they do not include specimen of labeling.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration, inspection and checking of automatic equipment is not performed according to a written program designed to assure proper performance.

Mar 22, 2019 inspection

• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output and 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.
• Procedures are written, and followed 21 CFR 211.130
  Procedures designed to assure that correct labels and labeling are used for drug products are not written.
• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments and apparatus is not done at suitable intervals in accordance with an established written program.
• 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.
• Records not made readily available to FDA 21 CFR 211.180(c)
  Records associated with drug product components, containers, closures, labeling and production and within the retention period for such records, were not made readily available for authorized inspection.
• Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
  Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations and precautions to be followed.
• 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.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over 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 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 calibration of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: manufacture; pack; repack.