# FDA WARNING_LETTER - Brand Packaging Group, Inc. - April 08, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/brand-packaging-group-inc/263be3ec-455a-4671-9823-ebf8cebe0013

> FDA WARNING_LETTER for Brand Packaging Group, Inc. on April 08, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Brand Packaging Group, Inc.
- Inspection Date: 2022-04-08
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The FDA inspected a dietary supplement facility at 75 & 85 Price Parkway, Farmingdale, NY, from March 29 to April 8, 2022, revealing significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 111. These violations render products, including (b)(4) and (b)(4), adulterated.

Key violations include:
1. **Failure to verify finished product specifications (21 CFR 111.75(c)):** The firm relied on production input for assay testing instead of analytical testing of finished products. The response was inadequate as it lacked specifications and test methods for microbiological testing.
2. **Failure to verify dietary ingredient identity (21 CFR 111.75(a)(1)(i)):** No testing was conducted on new dietary ingredients upon receipt; the firm used (b)(4) and (b)(4) for initial testing and as a standard. The adequacy of corrective actions, including purchasing a scientific database, could not be evaluated.
3. **Failure of quality control to reject non-conforming components/products (21 CFR 111.77(a), 111.113(b)(2)):** Ingredients like (b)(4) and (b)(4) did not meet identity specifications but were used without QC investigation. Corrective actions, such as SOP revisions

## Related Officers

- [Program Director](https://www.globalkeysolutions.net/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.globalkeysolutions.net/companies/brand-packaging-group-inc/782b1fd8-897a-422c-998e-84d2649a48dd

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961