FDA Inspection
R & R Lotion IncR & R Lotion Inc – FDA Inspection, Jun 6, 2016
Record Details
This FDA Inspection record concerns R & R Lotion Inc, with an inspection on June 6, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- R & R Lotion Inc
- Inspection Date
- June 6, 2016
- Product Type
- Drugs
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ID · f07cd056-c934-4fc1-a4a6-e4b778d5f9cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 974531
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
Showing 10 of 11 citations.
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Other FDA inspections of R & R Lotion Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2024 | VAI | Drug Quality Assurance | |
| May 23, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 26, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 4, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for R & R Lotion Inc
- FDA Inspection 1244273 - 2024-08-09
- FDA Inspection 783201 - 2012-05-23
- FDA Inspection 708053 - 2011-01-26
- FDA Inspection 561555 - 2009-02-04
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