Eniva USA, Inc.

Instruments - calibration (21 CFR 111.27(b))

You did not calibrate instruments or controls used in manufacturing or testing a component or dietary supplement to ensure the accuracy and precision of the instruments or controls.

Specifications - components (21 CFR 111.70(b))

For component(s) used in the manufacture of a dietary supplement, you did not establish necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met and limits on contamination to ensure the quality of the dietary supplement.

Specifications - finished dietary supplement (21 CFR 111.70(e))

You did not establish product specifications for identity, purity, strength and composition.

Component - verify identity, dietary ingredient (21 CFR 111.75(a)(1)(i))

You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.

Quality control production, process control; material review, disposition (21 CFR 111.113(a)(1))

Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met.

Batch record - follow master (21 CFR 111.255(c))

Your batch production record did not accurately follow the appropriate master manufacturing record.

Batch record - required information (21 CFR 111.260)

Your batch production record did not include all required information.

Examination, testing; appropriate (21 CFR 111.320(a))

You did not verify that the laboratory examination and testing methodologies are appropriate for their intended use.

Examination, testing; scientifically valid (21 CFR 111.320(b))

You did not identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification was met.

Conditions, controls -protect; microorganisms, contamination (21 CFR 111.365(a))

You did not perform manufacturing operations under conditions and controls that protect against the potential for contamination.

Scheduled process establishment (21 CFR 114.83)

A scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.

Re-confirm certificate of analysis (21 CFR 111.75(a)(2)(ii)(D))

You did not periodically re-confirm the supplier's certificate of analysis for a component.

Hair restraints (21 CFR 111.10(b)(6))

Your personnel did not wear hair restraints in an effective manner.

Food, gum, beverages, tobacco (21 CFR 111.10(b)(8))

Your personnel drank beverages in areas where components, dietary supplements, or contact surfaces are exposed or where contact surfaces are washed.

Hand-washing facilities (21 CFR 111.15(i))

Your hand-washing facilities are not adequate and do not furnish running water at a suitable temperature.

Equipment - procedures (21 CFR 111.25)

You did not follow written procedures for fulfilling the requirements for equipment and utensils.

Equipment - design - suitable (21 CFR 111.27(a))

You did not use equipment or utensils of appropriate design, construction, and workmanship to enable them to be adequately cleaned.

Contact surfaces - not in direct contact - cleaning (21 CFR 111.27(d)(4))

You did not clean surfaces that do not come into direct contact with components or dietary supplements as frequently as necessary to protect against contaminating components or dietary supplements.

Quality control production, process control; material review, disposition (21 CFR 111.113(a)(1))

Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met.

Quality control master manufacturing record; material review, disposition (21 CFR 111.113(a)(2))

Your quality control personnel did not conduct a material review and make a disposition decision when a batch deviated from the master manufacturing record.

Packaging description, representative label (21 CFR 111.210(g))

Your master manufacturing record did not include a representative label, or a cross-reference to the physical location of the actual or representative label.

Batch record - quality control review; monitoring (21 CFR 111.260(l)(1)(i))

Your batch production records did not include documentation that quality control personnel reviewed required monitoring operations.

Quality control, review, approve; investigate, follow-up (21 CFR 111.560(b))

Your quality control personnel did not review and approve decisions about whether to investigate a product complaint.