Hybrid Pharma, LLC

Warning LetterOpen

Ponswamy Rajalingam, Ph.D. Owner and President Hybrid Pharma, LLC 1015 West Newport Center Drive, Suite 106-A Deerfield Beach , FL 33442-7707 United StatesFEI 3011319445Issued Jun 7, 2022Office of Pharmaceutical Quality Operations, Division II

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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 3011319445.

Violations5

Issue DateJun 7, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Hybrid Pharma, LLC
Location: Ponswamy Rajalingam, Ph.D. Owner and President Hybrid Pharma, LLC 1015 West Newport Center Drive, Suite 106-A Deerfield Beach , FL 33442-7707 United States
FEI Number: 3011319445
Country: United States
Issue Date: June 07, 2022
Issuing Office: Office of Pharmaceutical Quality Operations, Division II
Product Type: Drugs
Status: Open

Summary

Hybrid Pharma, LLC, a registered outsourcing facility, produced compounded sterile drug products that failed to meet the regulatory conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for drug approval exemptions. During an FDA inspection from July to September 2021, investigators identified serious deficiencies in the facility's sterile drug manufacturing practices that put patients at risk and determined that the drugs produced violated the FDCA. The company's products did not comply with the necessary conditions for outsourcing facilities, including requirements for direct pharmacist supervision and adherence to current good manufacturing practices for sterile compounding.

Hybrid Pharma, LLC FDA Warning Letter, June 7, 2022