Drug factory · FDA FEI 3004106442

Bora Pharmaceuticals Inc.

6701 Evenstad Drive N, Maple Grove, MN, 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.

Dec 19, 2018 inspection

• Quality control - quality, dietary supplement 21 CFR 111.65
  You did not implement quality control operations to ensure the quality of the dietary supplement.
• Quality control - quality, dietary supplement 21 CFR 111.65
  You did not implement quality control operations to ensure the quality of the dietary supplement.
• Personnel dating/signing equipment log 21 CFR 211.182
  The persons performing the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log.
• Personnel dating/signing equipment log 21 CFR 211.182
  The persons performing the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log.
• Identification of each component or in-process material 21 CFR 211.188(b)(3)
  Batch production and control records do not include the specific identification of each batch of component used for each batch of drug product produced.
• Identification of each component or in-process material 21 CFR 211.188(b)(3)
  Batch production and control records do not include the specific identification of each batch of component used for each batch of drug product produced.
• 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.
• 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.
• Cleaning SOPs/schedules 21 CFR 211.67(b)(2)
  Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.
• Cleaning SOPs/schedules 21 CFR 211.67(b)(2)
  Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.

Dec 19, 2018 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.
• 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.

Mar 3, 2014 inspection

• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function.

Feb 28, 2011 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.
• 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.
• Packaging line inspection after use 21 CFR 211.130(e)
  Inspection of the packaging facilities is not done after use to assure that materials not suitable for subsequent operations have been removed.
• Packaging line inspection after use 21 CFR 211.130(e)
  Inspection of the packaging facilities is not done after use to assure that materials not suitable for subsequent operations have been removed.
• 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.
• 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.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the packing of a drug product lack the required to perform their assigned functions.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the packing of a drug product lack the required to perform their assigned functions.

Registered with FDA for: analysis; label; manufacture; pack.