Drugs · Dec 9, 2022

Premier Nutra Pharma Inc.

6 extracted findings

FDA source excerpt, selected passage

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

FDA published a close-out letter on Oct 18, 2023. The findings below are from the original warning letter.

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

Your firm failed to establish and follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)).

Your firm failed to establish written, approved procedures to prevent microbial contamination during the manufacturing operations of nasal spray OTC drug products at your facility. Specifically, your firm did not have an environmental monitoring program, did not perform any microbiological testing of facilities or equipment, and did not have established cleaning procedures or records. These conditions and practices increased the risk of contamination of the drug products your firm manufactured.

Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).

Failure to address violations may also cause the FDA to withhold issuance of Export Certificates. The FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 211.192 21 CFR 211.113(a)21 CFR 211.165(b)21 CFR 211.188 21 CFR 211.22(a)21 CFR 210

Premier Nutra Pharma Inc.

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