# FDA WARNING_LETTER - Pharmagen Laboratories, Inc - August 23, 2013

Source: https://www.globalkeysolutions.net/records/warning_letter/pharmagen-laboratories-inc/467afdc1-fd4b-4428-99e4-54d8ae98ec94

> FDA WARNING_LETTER for Pharmagen Laboratories, Inc on August 23, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pharmagen Laboratories, Inc
- Inspection Date: 2013-08-23
- Product Type: Drugs
- Office Name: New England District Office
- Summary: This FDA Warning Letter, CMS # 435786, dated October 24, 2014, addresses Pharmagen, Inc. following an inspection from August 5 to August 23, 2013, at their Stamford, CT facility. The inspection revealed serious deficiencies in sterile drug product production.

Key violations include:
- **Aseptic Technique Deficiencies:** Operators did not use proper aseptic technique for sterile gowning (e.g., no gloves, no sleeve covers) and leaned on aseptic work surfaces.
- **Environmental Control:** Failure to demonstrate adequate protection of ISO 5 areas by hoods, posing a significant contamination risk.
- **Unapproved New Drugs/Misbranding:** Prior to registering as a 503B outsourcing facility, Pharmagen produced drugs without valid prescriptions for individually-identified patients, rendering them unapproved new drugs (violating FDCA section 505(a)) and misbranded due to inadequate directions for use (violating section 502(f)(1)).
- **Insanitary Conditions:** Sterile drug products were prepared, packed, or held under insanitary conditions, causing them to be adulterated (violating section 501(a)(2)(A)).
- **CGMP Violations:** Significant Current Good Manufacturing Practice (CGMP) violations were observed, causing drug products to be adulterated (violating section 501(a

## Related Documents

- [483 - 2013-08-23](https://www.globalkeysolutions.net/records/483/pharmagen-laboratories-inc/d7e03fb0-4fad-4214-b1d7-5be7a300241a)
- [483 - 2013-08-23](https://www.globalkeysolutions.net/records/483/pharmagen-laboratories-inc/e7126fb7-a769-4b1b-a095-c11457e81b49)

## Related Officers

- [Scott K. Morton](https://www.globalkeysolutions.net/people/scott-k-morton/7ea97059-e010-4850-964d-35b46202f144)
- [District Director](https://www.globalkeysolutions.net/people/mutahar-shamsi/f1ed0c75-3167-41cb-a918-130aa6d0fb07)

Company: https://www.globalkeysolutions.net/companies/pharmagen-laboratories-inc/728e0eb0-4188-4475-bd35-b7a8e97ac272

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144