FDA Inspection
BioLyte Laboratories, LLCBioLyte Laboratories, LLC – FDA Inspection, Dec 18, 2019
Record Details
This FDA Inspection record concerns BioLyte Laboratories, LLC, with an inspection on December 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- BioLyte Laboratories, LLC
- Inspection Date
- December 18, 2019
- Product Type
- Drugs
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ID · 8977c65b-5019-43cf-9863-b1d2e3336c30
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1113105
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
10- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of BioLyte Laboratories, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2025 | Not classified | Detroit District Office | |
| April 27, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 6, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for BioLyte Laboratories, LLC
- FDA Inspection 1287796 - 2025-09-12
- FDA Inspection 1205037 - 2023-04-27
- FDA Inspection 1203096 - 2023-04-06
- FDA Inspection 1035012 - 2017-12-15
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