FDA Inspection
PREMIER NUTRA PHARMA Inc.PREMIER NUTRA PHARMA Inc. – FDA Inspection, Jul 8, 2022
Record Details
This FDA Inspection record concerns PREMIER NUTRA PHARMA Inc., with an inspection on July 8, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- PREMIER NUTRA PHARMA Inc.
- Inspection Date
- July 8, 2022
- Product Type
- Drugs
View Company Profile
ID · 92b89d35-bc0c-41b3-b515-ca8d035c18ed
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1173957
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
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