FDA Inspection
Allermed Laboratories, LLCAllermed Laboratories, LLC – FDA Inspection, Jan 31, 2024
Record Details
This FDA Inspection record concerns Allermed Laboratories, LLC, with an inspection on January 31, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · bd4165b9-7d80-4d5d-bcf0-343a661631f3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228221
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
FDA Citations
11- 21 CFR 600.80(c)(1)(i)Reporting Requirements - 15-day alert
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 600.14(c)When to report
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of Allermed Laboratories, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2018 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 14, 2017 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| July 13, 2015 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 12, 2013 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 27, 2011 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for Allermed Laboratories, LLC
- FDA Inspection 1071500 - 2018-11-12
- FDA Inspection 1022877 - 2017-06-14
- FDA Inspection 933388 - 2015-07-13
- FDA Inspection 843070 - 2013-08-12
- FDA Inspection 749646 - 2011-09-27
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