# FDA 483 - Mandell's Clinical Pharmacy - June 17, 2022

Source: https://www.globalkeysolutions.net/records/483/mandells-clinical-pharmacy/6b2e2d23-cf61-49d3-9e40-02ebb7703793

> FDA 483 for Mandell's Clinical Pharmacy on June 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mandell's Clinical Pharmacy
- Inspection Date: 2022-06-17
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Mandell's Clinical Pharmacy in Somerset, NJ, a producer of sterile and non-sterile drug products, revealed significant deficiencies in aseptic processing. Observations included inadequate media fills that did not simulate worst-case conditions, improper gowning practices, and a lack of assurance regarding ISO 5 air quality during sterile drug production. These issues indicate potential risks to the sterility and quality of drug products.

## Related Documents

- [145 - 2017-05-09](https://www.globalkeysolutions.net/records/145/mandells-clinical-pharmacy/5c084263-df51-4d7a-ae03-9daa617a3039)
- [483 - 2019-07-25](https://www.globalkeysolutions.net/records/483/mandells-clinical-pharmacy/cf76ed71-1b2b-4bb3-8db5-55d058459c87)
- [483 - 2019-07-25](https://www.globalkeysolutions.net/records/483/mandells-clinical-pharmacy/68be1d08-30e0-481e-8026-47e93a195bb3)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/sayyem-h-akbar/888c6b1b-7a62-4674-a73b-687c459db2f8)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/daniel-j-min/e8d901f7-c604-48e6-a723-f191dc3cd28c)
- [Adetutu M. Gidado](https://www.globalkeysolutions.net/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.globalkeysolutions.net/companies/mandells-clinical-pharmacy/8629ecab-c5d7-4f52-9f61-e6115b4de764

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