Premium Production LLC

Outer garments (21 CFR 111.10(b)(1))

Your personnel did not wear outer garments in a manner that protects against contamination of components, dietary supplements or contact surfaces.

Equipment - protect from contamination (21 CFR 111.27(a)(3)(v))

Your equipment or utensils are not maintained to protect components and dietary supplements from being contaminated.

In-process identity, purity, strength, composition (21 CFR 111.70(c)(1))

You did not establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for purity, strength and composition.

Specifications - identity, purity, strength, composition (21 CFR 111.70(e))

You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.

Appropriate tests, examinations; certificate of analysis (21 CFR 111.75(a)(2))

You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine whether components met established specifications.

Component - qualify supplier (21 CFR 111.75(a)(2)(ii)(A))

You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations.

Specifications met limits on contamination ; basis (21 CFR 111.75(c)(3))

You did not provide adequate documentation of your basis for determining that compliance with the specification you selected for the limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement will ensure that the finished batch of dietary supplement will not be adulterated as a result of such contamination.

Written procedures - quality control operations (21 CFR 111.103)

You did not establish and follow written procedures for quality control operations.

Master manufacturing record - each batch (21 CFR 111.205(a))

You did not prepare and follow a written master manufacturing record for each batch size of a dietary supplement that you manufactured.

Batch record - complete (21 CFR 111.255(b))

Your batch production record did not include complete information relating to the production and control of each batch.

Metal, foreign material (21 CFR 111.365(i))

You did not use effective measures to protect against the inclusion of metal or other foreign material in dietary supplements.

Written procedures -packaging operations (21 CFR 111.403)

You did not establish and follow written procedures for packaging operations.

Written procedures - product complaint (21 CFR 111.553)

You did not establish and follow written procedures for the requirements to review and investigate a product complaint.

Component - qualify supplier (21 CFR 111.75(a)(2)(ii)(A))

You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations.

Specifications met - verify; finished batch (21 CFR 111.75(c))

You did not verify that your finished batch of dietary supplement meets product specifications for limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement.

Written procedures - quality control operations (21 CFR 111.103)

You did not establish and follow written procedures for quality control operations.

Components - quarantine (21 CFR 111.155(c))

You did not quarantine components before you used them in the manufacture of a dietary supplement.

Master manufacturing record - each batch (21 CFR 111.205(a))

You did not prepare and follow a written master manufacturing record for each batch size of a dietary supplement that you manufactured.

Batch record - complete (21 CFR 111.255(b))

Your batch production record did not include complete information relating to the production and control of each batch.

Written procedures - labeling operations (21 CFR 111.403)

You did not establish and follow written procedures for labeling operations.

Written procedures - holding (21 CFR 111.453)

You did not establish and follow written procedures for holding and distributing operations.

Written procedures - product complaint (21 CFR 111.553)

You did not establish and follow written procedures for the requirements to review and investigate a product complaint.

Specifications - contamination limits (21 CFR 111.70(e))

You did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement.

Specifications - identity, purity, strength, composition (21 CFR 111.70(e))

You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.

Component - qualify supplier (21 CFR 111.75(a)(2)(ii)(A))

You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations.

Written procedures - quality control operations (21 CFR 111.103)

You did not establish and follow written procedures for quality control operations.

Components - quarantine (21 CFR 111.155(c))

You did not quarantine components before you used them in the manufacture of a dietary supplement.

Master manufacturing record - each batch (21 CFR 111.205(a))

You did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.

Batch record - complete (21 CFR 111.255(b))

Your batch production record did not include complete information relating to the production and control of each batch.

Written procedures - labeling operations (21 CFR 111.403)

You did not establish and follow written procedures for labeling operations.

Written procedures -packaging operations (21 CFR 111.403)

You did not establish and follow written procedures for packaging operations.

Written procedures - holding (21 CFR 111.453)

You did not establish and follow written procedures for holding and distributing operations.

Written procedures - product complaint (21 CFR 111.553)

You did not establish and follow written procedures for the requirements to review and investigate a product complaint.