Absolutely Natural

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 thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 2

You failed to conduct an adequate investigation in July 2024 when a batch of drug product failed microbiological testing due to out-of-specification (OOS) results for both total plate count and *Pseudomonas aeruginosa*. Although you rejected the batch, you failed to adequately assess the root cause of the microbiological contamination, and you failed to extend the investigation to additional batches that may also have been affected.

Passage 3

Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).

Passage 4

You failed to adequately validate your alternative rapid microbiological test methods. You use the **(b)(4)** system for rapid microbiological testing of your finished drug products (for example, total counts, objectionable microorganisms) and failed to demonstrate that it was equivalent to or better than United States Pharmacopeia (USP) compendial methods and suitable for its intended use. For example:

Passage 5

Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).

Passage 6

You failed to perform adequate identity testing of each incoming component lot, such as **(b)(4)**, used in the manufacture of your OTC drug products.

Passage 7

You failed to adequately test your incoming **(b)(4)**, which is used as an active pharmaceutical ingredient in your drug products, for **(b)(4)**. The use of **(b)(4)** contaminated with **(b)(4)** has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document **(b)(4)**.

Passage 8

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.