# FDA WARNING_LETTER - New Era Naturals, LLC - April 13, 2018

Source: https://www.keypedia.com/records/warning_letter/new-era-naturals-llc/14f82b35-7852-45ba-98a4-751b87634b35

> FDA WARNING_LETTER for New Era Naturals, LLC on April 13, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: New Era Naturals, LLC
- Inspection Date: 2018-04-13
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA inspected New Era Naturals, LLC, a drug manufacturing facility in Durango, Colorado, from March 5 to April 13, 2018, uncovering significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211). Consequently, the firm's drug products are considered adulterated under section 501(a)(2)(B) of the FD&C Act. Additionally, the drug products are not listed with FDA as required by section 510(j), rendering them misbranded.

Key CGMP violations include failure to perform final drug product testing for identity and strength of active ingredients (21 CFR 211.165(a)), and failure to test incoming raw materials or validate supplier analyses (21 CFR 211.84(d)(1) and (2)). The firm also lacked established written procedures for master and batch production records (21 CFR 211.186(a), 211.188) and failed to establish an adequate quality control unit (21 CFR 211.22(a)). Furthermore, the firm failed to list its OTC drug products, such as Zeb’s Organics Sunscreen, with the FDA, violating section 510 of the Act.

The FDA strongly recommended engaging a qualified CGMP consultant. The firm must respond within 15 working days, detailing corrective actions and a completion schedule. Failure to correct these violations may lead to legal action, including seizure and injunction, and could prevent approval of pending drug applications.

## Related Documents

- [483 - 2018-04-13](https://www.keypedia.com/records/483/new-era-naturals-llc/769c1774-1ea0-4847-8238-a5eebe0a2a47)

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.keypedia.com/companies/new-era-naturals-llc/4222b158-2f28-4a1a-862d-cd319c49bc90

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b