Drug factory · FDA FEI 1628196

Brio Pharmaceuticals, Inc

10863 Rockley Rd, Houston, TX, 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.

Feb 27, 2026 inspection

• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• 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.

Oct 3, 2018 inspection

• 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.
• 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.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are not 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 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 fully followed.
• input/output verification 21 CFR 211.68(b)
  Input to and output from the computer and records or data are not checked for accuracy.
• input/output verification 21 CFR 211.68(b)
  Input to and output from the computer and records or data are not checked for accuracy.

Mar 21, 2014 inspection

• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
• 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.
• 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.
• 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.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• Identification of Person Performing Review of Lab Records 21 CFR 211.194(a)(8)
  Laboratory records are deficient in that they do not include the signature of the second person reviewing the record for accuracy.
• Identification of Person Performing Review of Lab Records 21 CFR 211.194(a)(8)
  Laboratory records are deficient in that they do not include the signature of the second person reviewing the record for accuracy.
• 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.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, and instructions for protection of clean equipment from contamination prior to use.
• 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.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, and instructions for protection of clean equipment from contamination prior to use.
• 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.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the receipt and rejection of components, drug product containers, and closures.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the receipt and rejection of components, drug product containers, and closures.

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