Drug factory · FDA FEI 3005350897

Belleview Biosciences LLC

15431 Flight Path Dr, Brooksville, FL, United States

Serious problems, FDA action at FDA's last inspection, Mar 15, 2024.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

19 drug inspections on record since 2010: 2 with no problems, 5 with problems fixed voluntarily, 12 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Anhydrous Citric Acid	Makes it, packages it and labels it	Belleview Biosciences LLC	84447-017

FDA inspection history

Ended	Result	Program	Problems noted
Mar 15, 2024	Serious problems, FDA action	Drug Quality Assurance	7
Aug 20, 2021	Serious problems, FDA action	Drug Quality Assurance	4
Feb 15, 2019	Serious problems, FDA action	Drug Quality Assurance	6
Jan 25, 2017	Serious problems, FDA action	Drug Quality Assurance	9
Apr 1, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	3
Apr 1, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	5
Apr 1, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	6
Mar 30, 2012	Serious problems, FDA action	Drug Quality Assurance	5
Mar 30, 2012	Problems found, fixed voluntarily	Unapproved and Misbranded Drugs	—
Mar 30, 2012	Problems found, fixed voluntarily	Unapproved and Misbranded Drugs	—
Mar 30, 2012	Serious problems, FDA action	Unapproved and Misbranded Drugs	8
Mar 30, 2012	Serious problems, FDA action	Drug Quality Assurance	8
Mar 30, 2012	Serious problems, FDA action	Unapproved and Misbranded Drugs	6
Mar 30, 2012	Serious problems, FDA action	Drug Quality Assurance	6
Nov 24, 2010	Serious problems, FDA action	Drug Quality Assurance	6
Nov 24, 2010	No problems found	Drug Quality Assurance	—
Nov 24, 2010	No problems found	Drug Quality Assurance	—
Nov 24, 2010	Serious problems, FDA action	Drug Quality Assurance	8
Nov 24, 2010	Serious problems, FDA action	Drug Quality Assurance	4

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Mar 15, 2024 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 established, written and followed.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
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.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Component identification test 21 CFR 211.84(d)(2)
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.

Aug 20, 2021 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.
Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
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.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.

Feb 15, 2019 inspection

Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Microbiological testing 21 CFR 211.165(b)
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
Adequate number of batches on stability 21 CFR 211.166(b)
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
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.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

Jan 25, 2017 inspection

Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Microbiological testing 21 CFR 211.165(b)
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
Adequate number of batches on stability 21 CFR 211.166(b)
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
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.
Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Component identity verification 21 CFR 211.84(d)(1)
Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

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