# FDA 483 - Mandell's Clinical Pharmacy - July 25, 2019

Source: https://www.keypedia.com/records/483/mandells-clinical-pharmacy/68be1d08-30e0-481e-8026-47e93a195bb3

> FDA 483 for Mandell's Clinical Pharmacy on July 25, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mandell's Clinical Pharmacy
- Inspection Date: 2019-07-25
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: This FDA Form 483 document details observations from an inspection of Mandell's Clinical Pharmacy, a producer of sterile and non-sterile drug products, located at 7 Cedar Grove Ln, Suite 24, Somerset, NJ 08873-1331. The inspection was conducted on multiple dates between June 17, 2019, and July 25, 2019. The report was issued to Ms. Teresa Malanda, RPh, Pharmacist/Owner.

Key observations include:
1.  **Facility Design and Control:** An ISO 5 classified laminar flow hood for aseptic filling of sterile fertility drug products is located within a non-classified room, which is not HEPA filter equipped. Water was observed dripping from a ceiling vent near this ISO 5 area, raising contamination concerns.
2.  **Aseptic Process Validation:** Media fills were not performed to adequately simulate aseptic production operations. Specifically, no media fill was performed for the ISO 5 laminar flow hood in the unclassified room. Additionally, media fills for the ISO 5 biological safety cabinet used an insufficient number of units (b)(4) compared to typical batch sizes ranging from (b)(4) vials, failing to represent worst-case conditions.
3.  **Equipment Sterilization:** Non-depyrogenated equipment was used in sterile drug production. The (b)(4) used for mixing drug components

## Related Documents

- [145 - 2017-05-09](https://www.keypedia.com/records/145/mandells-clinical-pharmacy/5c084263-df51-4d7a-ae03-9daa617a3039)
- [483 - 2019-07-25](https://www.keypedia.com/records/483/mandells-clinical-pharmacy/cf76ed71-1b2b-4bb3-8db5-55d058459c87)
- [483 - 2022-06-17](https://www.keypedia.com/records/483/mandells-clinical-pharmacy/6b2e2d23-cf61-49d3-9e40-02ebb7703793)

## Related Officers

- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.keypedia.com/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)
- [Investigator](https://www.keypedia.com/people/nancy-m-espinal/f4494790-6a37-4998-853c-f859a0eb3330)

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

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