FDA Inspection
Tech Air of Naugatuck, LLCTech Air of Naugatuck, LLC – FDA Inspection, Oct 26, 2016
Record Details
This FDA Inspection record concerns Tech Air of Naugatuck, LLC, with an inspection on October 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Dien N. Nguyen (Issuing Officer)
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ID · 9907590b-33d7-4c58-ab0c-932739b0fa5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989772
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.100(b)SOPs not followed / documented
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