# FDA 483 - South Berwick Pharmacy Seacoast Compounding, Inc. - September 30, 2022

Source: https://www.globalkeysolutions.net/records/483/south-berwick-pharmacy-seacoast-compounding-inc/20cdb08a-500b-4e93-8d78-a2c936689674

> FDA 483 for South Berwick Pharmacy Seacoast Compounding, Inc. on September 30, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: South Berwick Pharmacy Seacoast Compounding, Inc.
- Inspection Date: 2022-09-30
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: South Berwick Pharmacy Seacoast Compounding, Inc. in South Berwick, ME, was inspected as a producer of non-sterile drugs and received a Form 483 with significant observations. The inspection revealed critical issues including inadequate controls to prevent cross-contamination of hazardous drugs, widespread non-microbial contamination and vermin in the production area, and the use of non-pharmaceutical grade and expired components in drug products. These conditions indicate serious deficiencies in facility control and quality assurance.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [M.S., Consumer Safety Officer at FDA](https://www.globalkeysolutions.net/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)

Company: https://www.globalkeysolutions.net/companies/south-berwick-pharmacy-seacoast-compounding-inc/767f09dc-b13f-49f4-a640-d2e17aa823bc

Office: https://www.globalkeysolutions.net/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94