PureChemPros LLC

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 adequately test your incoming components, including for identity, before using the components to manufacture your drug products. Additionally, you relied on certificates of analyses (COA) from unqualified suppliers for specifications such as purity, strength, and quality. By not adequately analyzing your components for identity, purity, strength, and quality, you failed to ensure that your incoming components meet appropriate specifications.

Passage 3

Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).

Passage 4

Your firm failed to implement an appropriate stability testing program. Your firm also lacked scientific rationale to support the associated labeled expiry or lack thereof. For example, you noted that any labeled expiry is based on the expiration date of the bulk concentrate active ingredient (i.e., benzalkonium chloride) used to manufacture your hand sanitizer drug products.

Passage 5

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.