Vegewax Candleworx Ltd.

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 (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 2

You failed to perform adequate identity testing for each component lot used in the production of your over-the-counter (OTC) drug products, including **(b)(4)**, your active pharmaceutical ingredient (API). Additionally, you did not test **(b)(4)** content and **(b)(4)** for the presence of **(b)(4)**. You relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your suppliers’ COA for component specifications and characteristics.

Passage 3

You failed to adequately investigate multiple microbiological excursions in samples collected from your **(b)(4)** system in **(b)(4)**. You also failed to isolate and speciate microorganisms, and to determine the root cause for out-of-limit (OOL) test results. In response to these excursions, you proposed CAPAs. However, your CAPAs were inadequate to prevent recurrence.