Drugs · Nov 21, 2024

Dr. Brite, LLC

7 extracted findings · 5 model-assigned issue types

FDA source excerpt, selected passage

Your firm failed to adequately test each shipment of your incoming components for identity, purity, strength, and quality before using the components to manufacture your drug products.

Labeling, claims & marketing Laboratory controls & testing Production & process controls Quality unit & oversight Registration, listing & premarket

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Production & process controls21 CFR 211.84(d)(1)

Failed to test each incoming component shipment for identity, purity, strength, and quality, including glycerin for DEG/EG contamination.

Supporting FDA text

Source excerpt · automated text-match check
Your firm failed to adequately test each shipment of your incoming components for identity, purity, strength, and quality before using the components to manufacture your drug products.

Laboratory controls & testing21 CFR 211.165(a)

Failed to conduct adequate finished product release testing for identity, strength, and objectionable microorganisms.

Supporting FDA text

Source excerpt · automated text-match check
Your firm failed to conduct adequate finished product release testing for each batch of your oral drug products and hand sanitizer drug products, including but not limited to, testing the identity and strength of active ingredients, and testing for objectionable microorganisms.

Quality unit & oversight21 CFR 211.22

Quality unit failed to ensure adequate oversight, including production controls, stability program, batch records, and training.

Supporting FDA text

Source excerpt · automated text-match check
Your firm failed to establish an adequate quality unit (QU) with responsibilities to ensure adequate oversight for the manufacture of your drug products.

Labeling, claims & marketing

Oral healthcare products are unapproved new drugs because they contain hydroxyapatite, not permitted under the anticaries monograph or the 2003 ANPR.

Supporting FDA text

Source excerpt · automated text-match check
These products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without an approved application.

Labeling, claims & marketing

Oral healthcare products are misbranded under section 502(ee) because they are nonprescription drugs subject to 505G but do not comply.

Supporting FDA text

Source excerpt · automated text-match check
these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

Labeling, claims & marketing21 CFR 201.66

Hand sanitizer and hand wipes are misbranded because they lack a Drug Facts panel.

Supporting FDA text

Source excerpt · automated text-match check
the labels for these products fail to include a Drug Facts panel.

Registration, listing & premarket21 CFR 207.17(a) 21 CFR 207.29

Establishment registration expired and drug listings were not updated, causing misbranding under section 502(o).

Supporting FDA text

Source excerpt · automated text-match check
Dr. Brite, LLC (FEI: 3016665985) has not fulfilled its establishment registration obligations and its registration expired on December 31, 2023.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

Your firm failed to test samples of each component for identity and conformity with

You failed to adequately test each shipment of each lot of glycerin for identity, a component at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. We note that glycerin is an ingredient used in some of your oral drug products, including those intended for infants and children. Records collected during the inspection show that your firm received at least one lot of glycerin from a region with confirmed or suspected contamination with high levels of DEG and EG.

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).

21 CFR 211.165(a)

Your firm failed to conduct adequate finished product release testing for each batch of your oral drug products and hand sanitizer drug products, including but not limited to, testing the identity and strength of active ingredients, and testing for objectionable microorganisms.

Your firm failed to establish an adequate quality unit (QU) with responsibilities to ensure adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure:

21 CFR 211.100(a)

Failure to register in accordance with section 510 of the FD&C Act and failure to provide listing information in accordance with 510(j) of the FD&C Act are prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p), and will render a drug misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

21 CFR 207

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

What FDA requested

Model-assisted summary. Consult the letter for complete requests and conditions.

A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.
A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective action and preventive action (CAPA) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the USP monograph.
The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.
A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.
A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
Provide a list of chemical and microbial test methods and specifications used to analyze each batch of your drug products before making a batch disposition decision, and the associated written procedures.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 201.66(b)(2)21 CFR 20721 CFR 211.84(d)(1)21 CFR 211.165(a)21 CFR 211.22 21 CFR 211.100(a)21 CFR 211.137(a)21 CFR 211.188 21 CFR 211.25(a)21 CFR 201.128 21 CFR 201.66 21 CFR 207.17(a)21 CFR 207.29 21 CFR 207.57(b)21 CFR 207.57(b)(2)21 CFR 21021 CFR 330

Dr. Brite, LLC

Findings and supporting evidence

Failed to test each incoming component shipment for identity, purity, strength, and quality, including glycerin for DEG/EG contamination.

Failed to conduct adequate finished product release testing for identity, strength, and objectionable microorganisms.

Quality unit failed to ensure adequate oversight, including production controls, stability program, batch records, and training.

Oral healthcare products are unapproved new drugs because they contain hydroxyapatite, not permitted under the anticaries monograph or the 2003 ANPR.

Oral healthcare products are misbranded under section 502(ee) because they are nonprescription drugs subject to 505G but do not comply.

Hand sanitizer and hand wipes are misbranded because they lack a Drug Facts panel.

Establishment registration expired and drug listings were not updated, causing misbranding under section 502(o).

Findings extracted from the letter

What FDA requested

Sections and clauses cited

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FDA Warning Letter Alerts

Findings and supporting evidence

Failed to test each incoming component shipment for identity, purity, strength, and quality, including glycerin for DEG/EG contamination.

Failed to conduct adequate finished product release testing for identity, strength, and objectionable microorganisms.

Quality unit failed to ensure adequate oversight, including production controls, stability program, batch records, and training.

Oral healthcare products are unapproved new drugs because they contain hydroxyapatite, not permitted under the anticaries monograph or the 2003 ANPR.

Oral healthcare products are misbranded under section 502(ee) because they are nonprescription drugs subject to 505G but do not comply.

Hand sanitizer and hand wipes are misbranded because they lack a Drug Facts panel.

Establishment registration expired and drug listings were not updated, causing misbranding under section 502(o).

Findings extracted from the letter

What FDA requested

Sections and clauses cited

More drug letters

Aidance Scientific, Inc.

Amazon.com, Inc.

Bioactive Services USA, LLC / Herstat Inc.

Keep exploring

Put this kind of reading towork on your own records.

Put this kind of reading to
work on your own records.