FDA Inspection
Speakman CoSpeakman Co – FDA Inspection, Mar 17, 2010
Record Details
This FDA Inspection record concerns Speakman Co, with an inspection on March 17, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Speakman Co
- Inspection Date
- March 17, 2010
- Product Type
- Drugs
View Company Profile
ID · 0ecc2b69-4bf2-4388-af72-77f01758c7c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 652027
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.134(c)Examinations documented
- 21 CFR 211.150Written distribution procedure
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Other FDA inspections of Speakman Co
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Speakman Co
- FDA Inspection 745366 - 2011-09-20
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