# FDA 483 - Coastal Meds, LLC - April 06, 2018

Source: https://www.keypedia.com/records/483/coastal-meds-llc/46441510-0f09-445b-83da-76470916eeed

> FDA 483 for Coastal Meds, LLC on April 06, 2018. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Coastal Meds, LLC
- Inspection Date: 2018-04-06
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations II
- Summary: The FDA Form 483 details significant deficiencies observed during an inspection of an outsourcing facility.

**Environmental Monitoring and Aseptic Processing:**
*   Environmental monitoring (EM) is inadequate, lacking samples in high-risk areas like the material pass-through box.
*   Fingertip and surface samples are taken improperly (e.g., after sanitization, on wet surfaces).
*   Pressure differential data is not reviewed, saved, or investigated, leading to unaddressed excursions (e.g., on 12/5/2017, impacting METHYLCOBALAMIN, Lot MC/120517).
*   Aseptic attire is deficient, as personnel do not wear goggles, exposing skin.
*   Pressure gauges for monitoring differentials are not calibrated.

**Laboratory Controls and Product Quality:**
*   Visual inspection of finished injectable products is inadequate due to lack of contrasting backgrounds and sufficient light, potentially missing quality issues.
*   Finished product release testing does not include content for preservatives used in all injectable drug products.
*   Sterilization process validation is deficient; the sterilizing method is not compliant with manufacturer's test methods or independently validated.
*   Media fill records lack critical information, including media preparation, materials used, filling process, and number of vials.

**Facility and Equipment Maintenance:**
*   Building construction materials within the ISO 7 cleanroom are unsuitable for cleaning solutions,

## Related Documents

- [483 - 2014-11-10](https://www.keypedia.com/records/483/coastal-meds-llc/cc6169f7-4ea4-45aa-b846-1dc52c2a5707)
- [483 - 2015-09-23](https://www.keypedia.com/records/483/coastal-meds-llc/80e659a9-2964-4a1a-8d9e-7741decca896)
- [OTHER_CORRESPONDENCE - 2018-03-12](https://www.keypedia.com/records/other_correspondence/coastal-meds-llc/7e561015-e211-4247-b9d7-521e65085206)

## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)

Company: https://www.keypedia.com/companies/coastal-meds-llc/f706471c-fa72-4716-8baa-e7d25c232a50

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-ii/930d696b-0ac7-4de4-8268-e3db00525bc6