WINDER Laboratories, LLC
Form 483 issued July 18, 2018 · WINDER, Georgia
- Inspection
- Jul 9 – Jul 18, 2018
- Investigators
- Johnetta F. Walters· Pratik S. Upadhyay
- Observations
- 13
- Pages
- 17
- FEI number
- 3008694072
In short: On July 18, 2018, FDA issued a Form 483 with 13 observations to WINDER Laboratories, LLC in WINDER, Georgia (FEI 3008694072) after an inspection that ran Jul 9 – Jul 18, 2018. The investigators were Johnetta F. Walters and Pratik S. Upadhyay. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Laboratory controls and facilities & equipment account for 8 of 13 observations.
Most cited: 21 CFR 211.22 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written test procedures and laboratory mechanisms are…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
The responsibilities and procedures applicable-to the quality control unit…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Johnetta F. Walters
3 documents · 2018–2019
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WINDER Laboratories, LLC?
FDA listed 13 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. 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.
Who inspected WINDER Laboratories, LLC?
Johnetta F. Walters and Pratik S. Upadhyay are named on this Form 483, for the inspection of Jul 9 – Jul 18, 2018. Each investigator has a profile showing what they cite most.
When was WINDER Laboratories, LLC inspected by FDA?
The inspection ran Jul 9 – Jul 18, 2018, and the Form 483 is dated July 18, 2018.
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.