Drug factory · FDA FEI 1000519407

Bryant Ranch Prepack

1919 North Victory Place, Burbank, 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.

Jul 16, 2026 inspection

• 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.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The control systems necessary to prevent contamination or mix-ups are deficient.
• Cleaning SOPs/equipment identification 21 CFR 211.67(b)(4)
  Procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of the previous batch identification.
• Systems in place to comply with verification requirements FDCA 582(b)(4)
  Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.

Mar 17, 2022 inspection

• 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.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
• 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.
• Quarantine Storage of Components 21 CFR 211.82(b)
  Incoming drug product containers and closures are not stored under quarantine until they have been tested or examined, as appropriate, and released.

Nov 18, 2019 inspection

• 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 investigations conducted for each drug product.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Dec 15, 2016 inspection

• 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 investigations conducted for each drug product.
• 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
• Quarantine of Rejected Components et. al. 21 CFR 211.89
  Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

Registered with FDA for: relabel; repack.