# FDA 483 - Pharmaceutical Manufacturing Research Services, Inc (PMRS) - May 25, 2017

Source: https://www.keypedia.com/records/483/pharmaceutical-manufacturing-research-services-inc-pmrs/f5a22e6b-02cb-45de-bdb3-fe444cf44435

> FDA 483 for Pharmaceutical Manufacturing Research Services, Inc (PMRS) on May 25, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutical Manufacturing Research Services, Inc (PMRS)
- Inspection Date: 2017-05-25
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Pharmaceutical Manufacturing Research Services, Inc. (PMRS) in Horsham, PA, from May 22-25, 2017, identified significant deficiencies in the firm's instrument calibration procedures. Specifically, issues were noted with the calibration of dissolution apparatus and pH meters, which are critical for testing stability samples and releasing finished drug products. These findings indicate a lack of adequate control over analytical equipment and testing processes.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [Consumer Safety Officer at FDA U.S. Food and Drug Administration](https://www.keypedia.com/people/ko-u-min/9bb5f33e-857b-4c6f-a550-fdb439760e30)
- [James M. Mason](https://www.keypedia.com/people/james-m-mason/a9f601a9-5d81-4386-90dc-80466edb5880)

Company: https://www.keypedia.com/companies/pharmaceutical-manufacturing-research-services-inc-pmrs/46e43916-458b-4d9f-8d90-0106b93f9908

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8