Turbare Manufacturing
Form 483 issued January 24, 2025 · Conway, Arkansas
- Inspection
- Jan 14 – Jan 24, 2025
- Investigator
- Logan T. Williams
- Observations
- 8
- Pages
- 7
- FEI number
- 3027507354
In short: On January 24, 2025, FDA issued a Form 483 with 8 observations to Turbare Manufacturing in Conway, Arkansas (FEI 3027507354) after an inspection that ran Jan 14 – Jan 24, 2025. The investigator was Logan T. Williams. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 6 of 8 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Employees engaged in the manufacture and processing of a drug product lack the training and experience…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmTurbare Manufacturing history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Turbare Manufacturing?
FDA listed 8 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Turbare Manufacturing?
Logan T. Williams is named on this Form 483, for the inspection of Jan 14 – Jan 24, 2025. Each investigator has a profile showing what they cite most.
When was Turbare Manufacturing inspected by FDA?
The inspection ran Jan 14 – Jan 24, 2025, and the Form 483 is dated January 24, 2025.
How do I get the full Form 483 for Turbare Manufacturing?
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.