# FDA 483 - Dr Marcs Manufacturing and Sales, LLC - April 27, 2018

Source: https://www.globalkeysolutions.net/records/483/dr-marcs-manufacturing-and-sales-llc/eb993641-7e9c-4f18-88b1-8f72ffccd3ed

> FDA 483 for Dr Marcs Manufacturing and Sales, LLC on April 27, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr Marcs Manufacturing and Sales, LLC
- Inspection Date: 2018-04-27
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: D. Marcs Manufacturing and Sales, LLC, an own label distributor of drug products in North Hills, CA, was cited for numerous significant deficiencies during an FDA inspection. The firm lacked fundamental quality control systems, written procedures for critical operations like stability testing, complaint handling, and distribution, and failed to ensure proper employee training and drug product storage conditions. These observations indicate a severe lack of basic GMP compliance.

## Related Officers

- [Stephanie A. Slater](https://www.globalkeysolutions.net/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)
- [Compliance Officer](https://www.globalkeysolutions.net/people/andrew-k-haack/d0e236ac-3223-43e0-8378-300de21b19f5)

Company: https://www.globalkeysolutions.net/companies/dr-marcs-manufacturing-and-sales-llc/6fc09826-3f8f-4c42-b807-3a4b057b0a9e

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