WINDER Laboratories, LLC
Form 483 issued March 13, 2020 · WINDER, Georgia
- Inspection
- Mar 9 – Mar 13, 2020
- Investigator
- Susan O. Oladeji
- Observations
- 4
- Pages
- 3
- FEI number
- 3008694072
In short: On March 13, 2020, FDA issued a Form 483 with 4 observations to WINDER Laboratories, LLC in WINDER, Georgia (FEI 3008694072) after an inspection that ran Mar 9 – Mar 13, 2020. The investigator was Susan O. Oladeji. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Complaint records are deficient in that they do not document the reason and the individual making…
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 211.63
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 quality system, facilities & equipment 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 Mar 9 – Mar 13, 2020. Each investigator has a profile showing what they cite most.
When was WINDER Laboratories, LLC inspected by FDA?
The inspection ran Mar 9 – Mar 13, 2020, and the Form 483 is dated March 13, 2020.
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.