FDA Inspection
Millers of Wyckoff, Inc.Millers of Wyckoff, Inc. – FDA Inspection, Jul 16, 2015
Record Details
This FDA Inspection record concerns Millers of Wyckoff, Inc., with an inspection on July 16, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Millers of Wyckoff, Inc.
- Inspection Date
- July 16, 2015
- Product Type
- Drugs
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ID · 6a0931aa-c5aa-48c1-9314-7f53b3de7d93
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 934124
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.42(b)Product flow through building is inadequate
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Other FDA inspections of Millers of Wyckoff, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 9, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 18, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Millers of Wyckoff, Inc.
- FDA Inspection 1132682 - 2020-10-09
- FDA Inspection 1018468 - 2017-05-18
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