FDA Inspection
Mon Healthcare, Inc.Mon Healthcare, Inc. – FDA Inspection, Oct 15, 2010
Record Details
This FDA Inspection record concerns Mon Healthcare, Inc., with an inspection on October 15, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mon Healthcare, Inc.
- Inspection Date
- October 15, 2010
- Product Type
- Drugs
View Company Profile
ID · 95a50a70-b5d8-4ed6-aa03-15bdf758c9af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 685509
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mon Healthcare, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mon Healthcare, Inc.
- FDA Inspection 806829 - 2012-11-07
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