Health Plus Inc.

Warning LetterOpen

Ms. Rita Mediratta President Health Plus Inc. 13837 Magnolia Avenue Chino , CA 91710 United States ritam@healthplusinc.comFEI 2027164Issued Dec 29, 2021Division of Pharmaceutical Quality Operations IV

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2027164.

Violations6

Issue DateDec 29, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Health Plus Inc.
Location: Ms. Rita Mediratta President Health Plus Inc. 13837 Magnolia Avenue Chino , CA 91710 United States ritam@healthplusinc.com
FEI Number: 2027164
Country: United States
Issue Date: December 29, 2021
Issuing Office: Division of Pharmaceutical Quality Operations IV
Product Type: Drugs
Status: Open

Summary

Health Plus Inc., a pharmaceutical drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering its drug products adulterated. During a June-July 2021 inspection, the FDA identified that the company failed to adequately inspect, investigate, and test returned drug products before redistributing them, relying solely on visual examination rather than proper testing to confirm safety, identity, strength, quality, and purity. Additionally, the firm improperly combined returned capsules from multiple lots into new batches with new lot numbers without ensuring uniform character and quality across the consolidated products.

Health Plus Inc. FDA Warning Letter, December 29, 2021