483
Monarch PCM, LLCMonarch PCM, LLC – FDA 483, Feb 6, 2018
Record Details
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.
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ID · fb2ba290-6480-40a9-9455-e9d1a3b184a4
Other documents for Monarch PCM, LLC
- 483 - 2021-08-20
- WARNING_LETTER - 2021-08-20
- EIR - 2018-02-06
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