# FDA 483 - Hopkinton Drug, Inc. - November 02, 2020

Source: https://www.globalkeysolutions.net/records/483/hopkinton-drug-inc/a3b718fa-61dc-4083-aa93-a71407f1e0fd

> FDA 483 for Hopkinton Drug, Inc. on November 02, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hopkinton Drug, Inc.
- Inspection Date: 2020-11-02
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Hopkinton Drug, Inc., a producer of non-sterile drug products in Hopkinton, MA, was cited for significant deficiencies during an FDA inspection. Observations included widespread non-microbial contamination in production areas, such as residues, staining, and facility degradation. The firm also failed to adequately segregate hazardous drug production, clean work surfaces, and maintain utensils, leading to cross-contamination risks.

## Related Documents

- [483 - 2020-11-02](https://www.globalkeysolutions.net/records/483/hopkinton-drug-inc/868dcd8e-9abb-42d6-a83b-8f0b4dd32738)

## 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)
- [Jonathan G Malvitziano](https://www.globalkeysolutions.net/people/jonathan-g-malvitziano/c3a7e7e2-38ad-4188-94b5-2b7137f5b3a4)

Company: https://www.globalkeysolutions.net/companies/hopkinton-drug-inc/0a8f5c5a-0fb8-479f-9b2e-4062b802a118

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7