# FDA 483 - Arnold Professional Pharmacy - September 05, 2018

Source: https://www.keypedia.com/records/483/arnold-professional-pharmacy/13717e0c-dc5c-4372-a2b0-876bafae4003

> FDA 483 for Arnold Professional Pharmacy on September 05, 2018. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arnold Professional Pharmacy
- Inspection Date: 2018-09-05
- Office Name: Baltimore District Office
- Summary: On September 5, 2018, the FDA issued a Form 483 to Arnold Professional Pharmacy in Arnold, MD, following an inspection conducted from August 21 to September 5, 2018. The facility, identified by FEI Number 3012283530, is a producer of non-sterile drug products. The report was issued to Neil P. McGarvey, Pharmacist.

The sole observation noted during the inspection was the use of a non-pharmaceutical grade component in the formulation of a drug product. Specifically, the firm utilized [(b)(4)] water in the production of a released and distributed drug product, Rx #[(b)(6)], Amlodipine 1mg/mL, intended for a pediatric population. This indicates a potential quality system and manufacturing issue related to raw material control and adherence to appropriate component standards for drug products. The document does not provide further details on business or operational implications beyond the observation itself.

## Related Documents

- [483 - 2016-05-06](https://www.keypedia.com/records/483/arnold-professional-pharmacy/7efb995a-47e6-417c-867a-5c38979d5552)
- [483 - 2018-09-05](https://www.keypedia.com/records/483/arnold-professional-pharmacy/a7e40b81-5c58-4d6d-8749-6bee291ac274)
- [UNTITLED_LETTER - 2018-09-05](https://www.keypedia.com/records/untitled_letter/arnold-professional-pharmacy/9d5e3f68-53c5-485a-9ae8-9b8704d4edf2)
- [483 - 2022-03-18](https://www.keypedia.com/records/483/arnold-professional-pharmacy/3567eaee-9c76-4cf5-8120-bb1f70030f61)
- [483 - 2022-03-18](https://www.keypedia.com/records/483/arnold-professional-pharmacy/526aa8a5-d3cb-4ff7-9e1c-b292f12d626b)

## Related Officers

- [Sena G. Dissmeyer](https://www.keypedia.com/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)

Company: https://www.keypedia.com/companies/arnold-professional-pharmacy/92c8dce6-da11-4ed6-a430-68a2d8383f8f

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa