# FDA 483 - PBM Nutritionals, LLC - August 15, 2019

Source: https://www.globalkeysolutions.net/records/483/pbm-nutritionals-llc/5ff35929-7d3a-4066-b6b4-da17add16245

> FDA 483 for PBM Nutritionals, LLC on August 15, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PBM Nutritionals, LLC
- Inspection Date: 2019-08-15
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of PBM Nutritionals, LLC, an infant formula manufacturer in Milton, VT, identified a significant concern regarding the cold storage of in-process infant formula. The firm failed to maintain appropriate temperatures and lacked sufficient data to support its holding procedures, raising potential risks of microbial growth. This indicates a critical lapse in quality control for a sensitive product.

## Related Documents

- [EIR - 2017-08-24](https://www.globalkeysolutions.net/records/eir/pbm-nutritionals-llc/6266a908-fbf7-45e5-8f17-9471fcc7eb5c)
- [483 - 2025-06-17](https://www.globalkeysolutions.net/records/483/pbm-nutritionals-llc/19700b14-e6b2-4552-8f65-0a59a24c9d16)

## Related Officers

- [Elizabeth P. Mayer](https://www.globalkeysolutions.net/people/elizabeth-p-mayer/aa5dbd87-75dd-4717-b141-32a76056bd08)
- [Gerard D DiBisce](https://www.globalkeysolutions.net/people/gerard-d-dibisce/44a14697-81db-4366-b3a5-85d3650c7915)
- [Alyssa Favro](https://www.globalkeysolutions.net/people/alyssa-favro/66d2f574-0b06-4574-a233-8d7badec66a4)

Company: https://www.globalkeysolutions.net/companies/pbm-nutritionals-llc/f5dc1699-927d-407d-a5d6-95a3711cd85c

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