FDA Inspection
Allermed Laboratories, LLCAllermed Laboratories, LLC – FDA Inspection, Nov 12, 2018
Record Details
This FDA Inspection record concerns Allermed Laboratories, LLC, with an inspection on November 12, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Arie Menachem (Issuing Officer)
- Colleen F. Hoyt (Issuing Officer)
View Company Profile
ID · 21d00121-97ee-4ab1-bab0-94d1a064e882
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071500
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Allermed Laboratories, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2024 | 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 1228221 - 2024-01-31
- 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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