Drug factory · FDA FEI 1000512361

Bora Pharmaceuticals Injectables Inc.

1111 S Paca St, Baltimore, MD, 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 16, 2021 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.
• Written records kept in individual logs 21 CFR 211.182
  Written records of major equipment use are not included in individual equipment logs.
• 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.
• Rejecting When Specifications Not Met 21 CFR 211.84(e)
  Failure to reject any lot of components, drug product containers and closures that did not meet the appropriate written specifications for identity, strength, quality, and purity.

Dec 20, 2016 inspection

• Second person sign off 21 CFR 211.194(a)(8)
  Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards.

Aug 28, 2015 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.

Aug 26, 2014 inspection

• 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.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

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