FDA Inspection
Thomas Respiratory Health CareThomas Respiratory Health Care – FDA Inspection, Dec 16, 2011
Record Details
This FDA Inspection record concerns Thomas Respiratory Health Care, with an inspection on December 16, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 16, 2011
- Product Type
- Drugs
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ID · 5c2b95f5-9a7c-498b-bb46-88ac411116f3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 758806
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
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