FDA Inspection
Northwest Respiratory Services LLCNorthwest Respiratory Services LLC – FDA Inspection, Mar 30, 2010
Record Details
This FDA Inspection record concerns Northwest Respiratory Services LLC, with an inspection on March 30, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 30, 2010
- Product Type
- Drugs
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ID · 422c2568-33fe-498c-a543-4f2688aafd4e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653643
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.188(a)Accurate reproduction included
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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