Premier Nutra Pharma Inc. — FDA Warning Letter Findings

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)). Your firm lacked a quality unit (QU) and failed to establish written procedures defining QU responsibilities and controls. For example, your firm failed to establish adequate procedures for reviewing and approving batch records prior to drug product release, annual product…

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). You manufactured drug products on behalf of your customer, (b)(4) . Your firm failed to perform an investigation into the microbial contamination of (b)(4) Nasal Spray batch (b)(4) . Furthermore, there was no evaluation of other drug product batches that may have been similarly contaminated, as you indicated that at least (b)(4) , a main ingredient in several drug products you manufactured for (b)(4) , were visibly contaminated with insects (bees) and/or yeast yet were still used in production. The inspection also documented that (b)(4) Nasal Spray drug product batch (b)(4) , released to the market, was also contaminated with yeast. Test results provided to you by your customer indicated at least three different samples of this lot having results for yeast greater than 20 CFU/g, with one as high as 70 CFU/g. We acknowledge that your customer voluntarily recalled the affected batch.

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. Furthermore, your firm failed to conduct appropriate laboratory testing of each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(b)).

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 lacked adequate batch production and control records for your manufacturing operations. Your firm indicated that you did not have production records, including batch records, for (b)(4) Nasal Spray batch (b)(4) . Although you provided records consisting of emails and initial master batch records, you failed to provide and maintain manufacturing batch records for your formulation, filling, and packaging operations, including equipment used, identification of person performing each step, description of components, complete labeling controls, and actual yield. Without adequate batch records, you cannot assure the uniformity of your drug products from batch to batch.