WINDER Laboratories, LLC
Form 483 issued February 3, 2023 · WINDER, Georgia
- Inspection
- Feb 3, 2023
- Investigator
- Susan O. Oladeji
- Observations
- 4
- Pages
- 7
- FEI number
- 3008694072
In short: On February 3, 2023, FDA issued a Form 483 with 4 observations to WINDER Laboratories, LLC in WINDER, Georgia (FEI 3008694072) after an inspection that ran Feb 3, 2023. The investigator was Susan O. Oladeji. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and sampling plans…
- 03
Written procedures are lacking which describe in sufficient detail…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Susan O. Oladeji
15 documents · 2017–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
The firmWINDER Laboratories, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WINDER Laboratories, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected WINDER Laboratories, LLC?
Susan O. Oladeji is named on this Form 483, for the inspection of Feb 3, 2023. Each investigator has a profile showing what they cite most.
When was WINDER Laboratories, LLC inspected by FDA?
The inspection ran Feb 3, 2023, and the Form 483 is dated February 3, 2023.
How do I get the full Form 483 for WINDER 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.