BioLyte Laboratories, LLC
FDA inspection history in Grand Rapids, Michigan, 2019 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2019: one Form 483; 2021: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–23Two Form 483s and one warning letter, at Grand Rapids, Michigan.
- 2019The longest 483 on file: 10 observations over 6 pages at Grand Rapids, Michigan.
Cited most
Across all BioLyte Laboratories observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.22(b)Responsibilities of quality control unit2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.113Control of microbiological contamination1
The complete BioLyte Laboratories file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Grand Rapids, Michigan
Two Form 483s and one warning letter · 2019 to 2023 · 17 observations
Latest: Form 483, Apr 27, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-27 | 483 Form 483 | Grand Rapids, Michigan | 7 | $99 |
| 2021-03-18 | Warning letter Warning letter | Grand Rapids, Michigan | — | $99 |
| 2019-12-18 | 483 Form 483 | Grand Rapids, Michigan | 10 | $99 |
FEI number 3013171766 · most recent document Apr 27, 2023
About BioLyte Laboratories, LLC
How many FDA Form 483s has BioLyte Laboratories, LLC received?
FDA Intel has 2 Form 483s on file for BioLyte Laboratories, LLC; the most recent is dated Apr 27, 2023.
When was BioLyte Laboratories, LLC last inspected by FDA?
The most recent FDA inspection document on file for BioLyte Laboratories, LLC is a Form 483 dated Apr 27, 2023, for the site in Grand Rapids, Michigan.
What did FDA cite at BioLyte Laboratories, LLC?
The regulations cited most in the observations on file for BioLyte Laboratories, LLC are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.166 (Stability testing), 2 times; 21 CFR 211.22(b) (Responsibilities of quality control unit), 2 times.
Has BioLyte Laboratories, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for BioLyte Laboratories, LLC; the most recent is dated Mar 18, 2021.