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FDA Inspection
•Natural Pharmaceutical Manufacturing LLC•May 24, 2012

Natural Pharmaceutical Manufacturing LLC – FDA Inspection, May 24, 2012

Record Details

This FDA Inspection record concerns Natural Pharmaceutical Manufacturing LLC, with an inspection on May 24, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Natural Pharmaceutical Manufacturing LLC
Inspection Date
May 24, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · dca016e9-b3c3-46db-9fc7-2cc090ee8b3c

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
781818
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

9
  1. 21 CFR 211.188(b)(1)Dates not included for each significant step
  2. 21 CFR 211.188(b)(3)Identification of each component or in-process material
  3. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  4. 21 CFR 211.194(a)(6)Test results, comparison with standards not included
  5. 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
  6. 21 CFR 211.184(a)Record information required
  7. 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
  8. 21 CFR 211.192Written record of investigation incomplete
  9. 21 CFR 211.182Written records kept in individual logs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Natural Pharmaceutical Manufacturing LLC

3
DateClassificationOfficeProject area
June 23, 2022NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 15, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 17, 2010NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Natural Pharmaceutical Manufacturing LLC
  • FDA Inspection 1176030 - 2022-06-23
  • FDA Inspection 1014422 - 2017-06-15
  • FDA Inspection 679380 - 2010-08-17

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