# FDA WARNING_LETTER - THE COMPOUNDING SHOP, INC. - September 03, 2013

Source: https://www.keypedia.com/records/warning_letter/the-compounding-shop-inc/b4d736f0-0ad7-46fb-b0f4-98a022b96a13

> FDA WARNING_LETTER for THE COMPOUNDING SHOP, INC. on September 03, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: THE COMPOUNDING SHOP, INC.
- Inspection Date: 2013-09-03
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: The FDA issued a Warning Letter to The Compounding Shop, Inc. following inspections from March 18-22, 2013, and August 23-September 3, 2013. The inspections revealed significant violations of the Federal Food, Drug, and Cosmetic Act (FDCA).

Key violations include:
- **Lack of Valid Prescriptions:** The firm produced drug products without receiving valid prescriptions for individually-identified patients, violating Section 503A of the FDCA and the agency's Compliance Policy Guide 460.200.
- **Domperidone Production:** The firm continued to produce domperidone drug products despite prior warnings in 2005. Domperidone is not subject to an applicable USP/NF monograph, is not a component of an FDA-approved human drug, and is not on a Secretary-developed list, making its compounded products ineligible for Section 503A exemptions.
- **Insanitary Sterile Drug Production:** Serious deficiencies were observed in sterile drug product practices, including storing facility-dedicated clothing near a toilet, placing non-disinfected materials in an ISO 5 hood, personnel moving over open vials, hand-stoppering, and using non-sterile wipes/mats in an ISO 5 hood. These conditions render sterile products adulterated under FDCA Section 501(a)(2)(A).
- **Lack of Testing

## Related Documents

- [483 - 2013-09-03](https://www.keypedia.com/records/483/the-compounding-shop-inc/2befa7fa-4557-44e3-8d72-f4b0618b66f5)

## Related Officers

- [Elizabeth W. Ormond](https://www.keypedia.com/people/elizabeth-w-ormond/55f8bf5b-dbd6-4cd5-b3de-7606dec3727c)

Company: https://www.keypedia.com/companies/the-compounding-shop-inc/588ce438-9801-4c88-8348-eb8e03611eef

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9