BEO Pharma Inc. dba BEO Pharmaceuticals Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 2

You failed to perform adequate incoming testing of each component lot used in the manufacture of your over-the-counter (OTC) liquid drug products, such as **(b)(4)**, and **(b)(4)**. For example, you failed to adequately test each lot of active pharmaceutical ingredient (API) for identity prior to use in your OTC drug products. In addition, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.

Passage 3

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).

Passage 4

Your firm failed to establish an adequate quality unit (QU) to oversee the manufacture of your drug products. For example, your QU approved drug products for release without complete finished product testing. Your firm shipped a batch of **(b)(4)** to your customer on January 8, 2024; however, microbial testing for that batch was not received until January 10, 2024. Your QU approved the release of this batch, which stipulated all required test results for this batch were complete on December 24, 2023.

Passage 5

Your firm failed to retain reserve samples of incoming raw materials, including APIs and high-risk components, in accordance with your written procedure.

Passage 6

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Passage 7

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Passage 8

Your firm failed to demonstrate that your microbiological test methods were appropriate to assure that your product conforms to appropriate standards of identity, strength, quality, and purity. Specifically, you could not provide evidence of method suitability for microbiological testing performed by your third-party laboratory. The ability of microbial testing methods to detect objectionable microorganisms in the presence of each drug product must be established.

Passage 9

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.