# FDA 483 - Armstrong Pharmaceuticals, Inc. - November 13, 2009

Source: https://www.keypedia.com/records/483/armstrong-pharmaceuticals-inc/52cb8991-414d-4f7b-8fa7-8dc826f3049f

> FDA 483 for Armstrong Pharmaceuticals, Inc. on November 13, 2009. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Armstrong Pharmaceuticals, Inc.
- Inspection Date: 2009-11-13
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Armstrong Pharmaceuticals, Inc. in West Roxbury, MA, was inspected, revealing significant issues with equipment design, validation, and quality control for Epinephrine manufacturing. The inspection found unqualified equipment used for product release, failures to investigate discrepancies thoroughly, and the use of out-of-tolerance analytical balances. These observations indicate a moderate level of severity regarding quality system deficiencies.

## Related Officers

- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)
- [FDA Investigator - Drugs Team at US Department of Health and Human Services](https://www.keypedia.com/people/rory-geyer/9f164dc5-df4d-4ecd-83d0-60fe6e73cf22)

Company: https://www.keypedia.com/companies/armstrong-pharmaceuticals-inc/8207964e-09ec-4ef4-8657-3058c43ab339

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