FDA Inspection
PDQ Manufacturing IncPDQ Manufacturing Inc – FDA Inspection, Sep 15, 2016
Record Details
This FDA Inspection record concerns PDQ Manufacturing Inc, with an inspection on September 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- PDQ Manufacturing Inc
- Inspection Date
- September 15, 2016
- Product Type
- Drugs
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ID · 2aee26d9-1cdd-4cc3-85f3-41c0fe25603d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987076
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.67(b)Written procedures not established/followed
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