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# Dietary Supplement CGMP Violations at Nutra Solutions
- URL: https://www.fdaweb.com/dietary-supplement-cgmp-violations-at-nutra-solutions/
- Published: 2019-09-24T12:00:00.000Z
- Updated: 2026-09-15T01:51:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145077

A 3/21-4/9 FDA inspection at the Nutra Solutions contract dietary supplement manufacturing facility in Deer Park, NY, found serious violations of current good manufacturing practice (CGMP) regulations for manufacturing, packaging, labeling, or holding operations for dietary supplements. A 9/12 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nutra-solutions-usa-inc-570011-09122019?ref=fdaweb.com) says the significant violations were: 

- failing to establish product specifications for the identity and purity of the finished batch of dietary supplement that is manufactured;
- failing to establish an identity specifications for each component used in the manufacture of a dietary supplement;
- quality control operations failed to determine whether all in-process specifications established in accordance with regulations were met;
- failing to examine, before packaging and labeling operations, packaging and labeling for each batch of dietary supplement to determine whether the packaging and labeling conforms to the master manufacturing record;
- the firm’s master manufacturing record fails to include all information required by regulations; and
- the batch production record failed to include complete information relating to the production and control of each batch.

Nutra Solutions was told that it is responsible for investigating and determining the causes of the violations identified in the letter and prevent their recurrence or the occurrence of other violations. It was told to respond with a list of specific actions taken to correct the violations, with an explanation and documentation of each step, and a timetable for completion.