BioLyte Laboratories, LLC
Form 483 issued April 27, 2023 · Grand Rapids, Michigan
- Observations
- 7
- Pages
- 8
- FEI number
- 3013171766
In short: On April 27, 2023, FDA issued a Form 483 with 7 observations to BioLyte Laboratories, LLC in Grand Rapids, Michigan (FEI 3013171766). Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Specific identification tests are not conducted on components that have been accepted based on the…
- 02
The written stability program for drug products does not include reliable, meaningful…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and sampling plans…
This inspection in context
Questions about this 483
What did FDA find at BioLyte Laboratories, LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and materials. The opening words of each observation are shown on this page.
When was BioLyte Laboratories, LLC inspected by FDA?
This Form 483 is dated April 27, 2023.
How do I get the full Form 483 for BioLyte Laboratories, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.