FDA Inspection
Harry J Bosworth CompanyHarry J Bosworth Company – FDA Inspection, Dec 14, 2009
Record Details
This FDA Inspection record concerns Harry J Bosworth Company, with an inspection on December 14, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Harry J Bosworth Company
- Inspection Date
- December 14, 2009
- Product Type
- Drugs
View Company Profile
ID · 8d181c39-9ef2-4220-8d91-f212d32971c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635745
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(b)(3)(i)Management representative implementing the quality system
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Other FDA inspections of Harry J Bosworth Company
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 11, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Harry J Bosworth Company
- FDA Inspection 829279 - 2013-04-26
- FDA Inspection 709641 - 2011-02-11
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