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FDA Inspection
•R & R Lotion Inc•February 4, 2009

R & R Lotion Inc – FDA Inspection, Feb 4, 2009

Record Details

This FDA Inspection record concerns R & R Lotion Inc, with an inspection on February 4, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
R & R Lotion Inc
Inspection Date
February 4, 2009
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · d730f29d-7f21-4dc7-b83e-5b834f627b58

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
561555
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

5
  1. 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
  2. 21 CFR 211.25(b)Supervisor Training/Education/Experience
  3. 21 CFR 211.165(a)Testing and release for distribution
  4. 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
  5. 21 CFR 211.180(e)(2)Items to cover on annual reviews

Full citation text and observation details available on the Dashboard.

Other FDA inspections of R & R Lotion Inc

4
DateClassificationOfficeProject area
August 9, 2024VAIDrug Quality Assurance
June 6, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 23, 2012NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 26, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for R & R Lotion Inc
  • FDA Inspection 1244273 - 2024-08-09
  • FDA Inspection 974531 - 2016-06-06
  • FDA Inspection 783201 - 2012-05-23
  • FDA Inspection 708053 - 2011-01-26

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