Drug factory · FDA FEI 2021236

B. Braun US Pharmaceutical Manufacturing LLC

2525 McGaw Avenue, Irvine, CA, 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.

Nov 21, 2025 inspection

• Acceptance of drug products 21 CFR 211.160(b)(3)
  Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established specifications are not rejected.
• 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.
• 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 / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Written Procedures Not Followed 21 CFR 211.80(a)
  Written procedures are not followed for the approval of components.

Dec 15, 2023 inspection

• Sampling and testing plans not followed 21 CFR 211.165(c)
  Written procedures for sampling and testing plans are not followed for each drug product.
• Representative Number of Batches for Annual Review 21 CFR 211.180(e)(1)
  The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of a representative number of batches.
• 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.

Jun 29, 2018 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• 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 drug products conform to appropriate standards of identity, strength, quality and purity.
• Test methods 21 CFR 211.165(e)
  The accuracy and specificity of test methods have not been established and documented.
• 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.
• Description and Identification of Samples 21 CFR 211.194(a)(1)
  Laboratory records are deficient in that they do not include a description and identification of the sample received, quantity, lot number, date sample taken and date sample received for testing.
• Complete Test Data 21 CFR 211.194(a)(4)
  Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
• 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.

Mar 3, 2015 inspection

• Records reviewed annually 21 CFR 211.180(e)
  Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
• 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 Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or 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.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.

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