FDA Inspection
Maple Rose Enterprises, Inc, dba Pencol PharmacyMaple Rose Enterprises, Inc, dba Pencol Pharmacy – FDA Inspection, Feb 26, 2019
Record Details
This FDA Inspection record concerns Maple Rose Enterprises, Inc, dba Pencol Pharmacy, with an inspection on February 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 26, 2019
- Product Type
- Drugs
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ID · 1e2a1934-c76c-4509-8235-a3903eca07bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1080560
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.84(d)(6)Objectionable microbiological contamination
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Maple Rose Enterprises, Inc, dba Pencol Pharmacy
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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