# FDA 483 - Town and Country Compounding and Consultation Services, LLC - August 22, 2016

Source: https://www.keypedia.com/records/483/town-and-country-compounding-and-consultation-services-llc/f7096da6-1eab-407c-a1f4-4336ac586d2a

> FDA 483 for Town and Country Compounding and Consultation Services, LLC on August 22, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Town and Country Compounding and Consultation Services, LLC
- Inspection Date: 2016-08-22
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: This FDA Form 483 details multiple significant violations at a drug manufacturing facility.

**Facility and Operations:** The facility produces various drug products, including sterile injectables like Sermorelin/GHRP-6, HCG, Glutathione, Atropine, Morphine-Clonidine-Baclofen Intrathecal, Penicillin G, and Anastrozole. Operations involve compounding, lyophilization, and sterile filling.

**Violations and Observations:**

*   **Failure to Reject Non-Conforming Products:**
    *   Twelve vials of Sermorelin/GHRP-6 Lot # 07172016@1 were dispensed despite a confirmed sterility failure and without final review/approval.
    *   HCG Lot # 05272016@17, Glutathione Lot # 120414AS, and Atropine Lot # 063015DS had potency values outside specifications (74.3%, 82.86%, 91.70% respectively). HCG was dispensed. Glutathione and Atropine formulations were subsequently dispensed in other lots without ensuring potency within specifications for Beyond Use Dating.
*   **Deficient Microbiological Contamination Prevention:**
    *   Poor aseptic practices observed: incomplete sanitization of supplies entering ISO 6/7 rooms, and no disinfection of supplies entering the ISO 5 laminar

## Related Documents

- [WARNING_LETTER - 2016-08-22](https://www.keypedia.com/records/warning_letter/town-and-country-compounding-and-consultation-services-llc/61c22e2f-7045-4586-8f83-634c05d87af1)

## Related Officers

- [CSO](https://www.keypedia.com/people/nancy-f-scheraga/7ab7500d-901f-4953-95a7-4a2b22488f04)
- [Liatte Krueger](https://www.keypedia.com/people/liatte-krueger/cbfda638-7610-43d9-9301-2e010665c86d)

Company: https://www.keypedia.com/companies/town-and-country-compounding-and-consultation-services-llc/18acc515-a4f0-4100-ae6b-1c55632fc9a2

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248