BioLyte Laboratories, LLC
Form 483 issued December 18, 2019 · Grand Rapids, Michigan
- Inspection
- Dec 9 – Dec 18, 2019
- Observations
- 10
- Pages
- 6
- FEI number
- 3013171766
In short: On December 18, 2019, FDA issued a Form 483 with 10 observations to BioLyte Laboratories, LLC in Grand Rapids, Michigan (FEI 3013171766) after an inspection that ran Dec 9 – Dec 18, 2019. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
GMP training is not conducted on a continuing basis to assure that employees remain familiar with…
- 03
Master production and control records lack complete…
- 04
Changes to written procedures are not drafted, reviewed and approved by…
This inspection in context
Questions about this 483
What did FDA find at BioLyte Laboratories, LLC?
FDA listed 10 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was BioLyte Laboratories, LLC inspected by FDA?
The inspection ran Dec 9 – Dec 18, 2019, and the Form 483 is dated December 18, 2019.
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.