FDA Inspection
John W Hollis IncJohn W Hollis Inc – FDA Inspection, Mar 21, 2014
Record Details
This FDA Inspection record concerns John W Hollis Inc, with an inspection on March 21, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- John W Hollis Inc
- Inspection Date
- March 21, 2014
- Product Type
- Drugs
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ID · 08c376d1-e51e-4063-9fea-3bdf1a5212c9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 872604
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
Showing 10 of 11 citations.
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Other FDA inspections of John W Hollis Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for John W Hollis Inc
- FDA Inspection 967247 - 2016-02-05
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