# FDA WARNING_LETTER - Precise Nutrition International, Inc. - December 21, 2012

Source: https://www.keypedia.com/records/warning_letter/precise-nutrition-international-inc/134db260-3cdd-4d28-bb5b-15846a4bfaea

> FDA WARNING_LETTER for Precise Nutrition International, Inc. on December 21, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Precise Nutrition International, Inc.
- Inspection Date: 2012-12-21
- Product Type: Food
- Office Name: Los Angeles District Office
- Summary: On July 11, 2013, the FDA issued a Warning Letter to Precise Nutrition International, Inc. following an inspection from December 10-21, 2012. The inspection revealed serious violations of dietary supplement CGMP regulations (21 CFR Part 111), causing their VitalErotic Shot product to be adulterated.

Key violations include:
1.  **Failure to verify identity of dietary ingredients (21 CFR 111.75(a)(1)(i)):** The firm relied solely on supplier COAs for ingredients like L-Arginine HCL and Yohimbine HCL, which is insufficient. The firm's response was inadequate as no documentation of implemented corrective action was provided.
2.  **Failure to establish specifications (21 CFR 111.70):** No specifications were established for component identity, purity, strength, composition, or contamination limits. Additionally, there were no in-process specifications for bulk liquid storage time (observed 11-199 days between blending and filling) or documentation to support product quality after such storage. The firm's response lacked documentation of implemented procedures and detailed stability study parameters.
3.  **Failure to verify finished product specifications (21 CFR 111.75(c)):** Six of seven VitalErotic Shot lots lacked documentation of finished product testing. The firm's stated "

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Company: https://www.keypedia.com/companies/precise-nutrition-international-inc/e97ddcb4-7dbf-4a21-96d6-02e81483c331

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