# FDA 483 - Monarch PCM, LLC - February 06, 2018

Source: https://www.keypedia.com/records/483/monarch-pcm-llc/fb2ba290-6480-40a9-9455-e9d1a3b184a4

> FDA 483 for Monarch PCM, LLC on February 06, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Monarch PCM, LLC
- Inspection Date: 2018-02-06
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Monarch PCM LLC in Fort Worth, TX, a drug manufacturer, revealed a significant lapse in quality control procedures. The firm failed to establish written procedures for Annual Product Reviews (APRs) and did not conduct these reviews for its Over-the-Counter human drugs in 2017. This indicates a serious deficiency in ensuring ongoing product quality and compliance.

## Related Documents

- [EIR - 2018-02-06](https://www.keypedia.com/records/eir/monarch-pcm-llc/8f640c0c-957f-4029-8b89-659e78cb80a2)
- [483 - 2021-08-20](https://www.keypedia.com/records/483/monarch-pcm-llc/a99481c5-4df3-44c2-a5c4-c20b3fedbfee)
- [WARNING_LETTER - 2021-08-20](https://www.keypedia.com/records/warning_letter/monarch-pcm-llc/4c4d52f4-8239-48e7-b083-cca2959d1604)

## Related Officers

- [Cornerstone Brands Inc.](https://www.keypedia.com/people/lisa-whitt/6c1ca4bf-d015-4dc0-8f95-dfb72d190b31)

Company: https://www.keypedia.com/companies/monarch-pcm-llc/ee588fdf-02dc-4629-9dee-c06da9214f78

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9