# FDA 483 - Shireen V. Guide, M.D. - October 07, 2022

Source: https://www.keypedia.com/records/483/shireen-v-guide-md/b2baf540-fd97-4e0e-8167-9a294601cc71

> FDA 483 for Shireen V. Guide, M.D. on October 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shireen V. Guide, M.D.
- Inspection Date: 2022-10-07
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Shireen V. Guide, M.D. in Rancho Santa Margarita, CA, a clinical investigator, revealed significant deviations from the investigational plan. The observations included instances where subjects received incorrect investigational product, study drugs were not stored according to the pharmacy manual, and randomization dates were incorrectly documented. These issues indicate a failure to adhere to established protocols for clinical investigations.

## Related Officers

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Company: https://www.keypedia.com/companies/shireen-v-guide-md/4ed4bde6-eb90-44e0-bc5e-5c1002904119

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6