# FDA EIR - Rhodes Pharmaceuticals, L.P. - July 27, 2016

Source: https://www.globalkeysolutions.net/records/eir/rhodes-pharmaceuticals-lp/a1983b7e-1d4a-48d2-80bb-db979c1f81a2

> FDA EIR for Rhodes Pharmaceuticals, L.P. on July 27, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Rhodes Pharmaceuticals, L.P.
- Inspection Date: 2016-07-27
- Product Type: Drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Rhodes Pharmaceuticals, L.P., located in Coventry, RI, was conducted from July 13 to July 27, 2016. This comprehensive review, performed under Compliance Programs 7356.002 (Drug Process Inspections) and 7352.832 (ANDA Pre-approval Inspection), focused on the company's Quality and Laboratory Systems. Rhodes Pharmaceuticals functions as a virtual entity, overseeing Contract Manufacturing Organizations for production, packaging, and most testing activities, while providing quality assurance and regulatory management.

Despite no formal Form FDA 483 observations being issued during the close-out meeting, the inspection highlighted two key areas. The Quality Unit's review of an Annual Product Review for Dilaudid Oral Liquid was significantly delayed by nearly five months beyond its contract manufacturer's approval. Rhodes Pharmaceuticals committed to rectifying this by allocating additional personnel to ensure timely future reviews. Additionally, the analytical laboratory presented sanitation deficiencies, including the presence of dead insects on equipment and in light fixtures. Management promptly addressed this by cleaning the affected areas and engaging their pest control provider for a preventative maintenance plan. These proactive corrective measures taken during the inspection averted formal observations. The previous 2012 inspection had identified a minor issue related to timely Field Alert Report submission, which was confirmed as corrected.

## Related Documents

- [483 - 2025-09-26](https://www.globalkeysolutions.net/records/483/rhodes-pharmaceuticals-lp/c2aa0816-5d02-4820-8cae-1a503a42560f)

## Related Officers

- [recipient](https://www.globalkeysolutions.net/people/vincent-mancinelli-ii/04776aab-6a7f-4f18-a41c-5c8d37b002df)
- [company_representative](https://www.globalkeysolutions.net/people/kevin-kolar/16612194-847d-4eaf-a8cc-5a260d45e1fd)
- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [company_representative](https://www.globalkeysolutions.net/people/qi-hong/512111c3-78a9-42ba-a6af-d13c0e6824eb)
- [company_representative](https://www.globalkeysolutions.net/people/david-fogel/59334604-02a5-42fc-b7fe-75371ec6eea1)

Company: https://www.globalkeysolutions.net/companies/rhodes-pharmaceuticals-lp/064f9115-958c-4252-8ded-dc4c4edb32c4

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