# FDA WARNING_LETTER - Harmonic Nature S. de R.L. MI. - August 12, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/harmonic-nature-s-de-rl-mi/753466fb-9b6f-4361-a294-795e40dcf6d0

> FDA WARNING_LETTER for Harmonic Nature S. de R.L. MI. on August 12, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Harmonic Nature S. de R.L. MI.
- Inspection Date: 2020-08-12
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Harmonic Nature S. de R.L. MI. (Mr. Martinez) on November 16, 2020, following the detention and refusal of admission of their "Alcohol Antiseptic 75% Topical Solution Hand Sanitizer" product at the U.S. border. FDA laboratory testing revealed the product, labeled to contain 75% ethyl alcohol, actually contained 0% ethanol and 38% 1-propanol, a dangerous chemical not permitted in hand sanitizers.

This constitutes adulteration under section 501(d)(2) of the FD&C Act due to substitution of the active ingredient, and 501(a)(2)(B) due to a non-functioning quality assurance system. The product is also an unapproved new drug (505(a)) and misbranded (502(a), (e), (ee)) because its labeling is false/misleading, it fails to list 1-propanol as an ingredient, and it does not comply with OTC drug marketing requirements or FDA's temporary COVID-19 policies for hand sanitizers.

The FDA recommended a voluntary nationwide recall, which the firm initiated on August 14, 2020. The firm is required to provide a detailed investigation into the substitution, a list of all raw materials and suppliers, a list and reconciliation of all batches shipped to the

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Mario Hidalgo](https://www.globalkeysolutions.net/people/mario-hidalgo/98a5cc0f-4696-4df0-9369-75d8d7b02e9e)

Company: https://www.globalkeysolutions.net/companies/harmonic-nature-s-de-rl-mi/cc86153a-bd7f-4aa3-9824-5cd8b9cb46f6

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c