Midlab Incorporated
Form 483 issued August 5, 2022 · Athens, Tennessee
- Inspection
- Aug 1 – Aug 5, 2022
- Investigator
- Clinton J. Lott
- Observations
- 6
- Pages
- 5
- FEI number
- 3001236208
In short: On August 5, 2022, FDA issued a Form 483 with 6 observations to Midlab Incorporated in Athens, Tennessee (FEI 3001236208) after an inspection that ran Aug 1 – Aug 5, 2022. The investigator was Clinton J. Lott. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
There is no written testing program designed to assess the stability…
- 04
Drug product component testing is deficient in that at least one specific test to verify the…
This inspection in context
Clinton J. Lott
10 documents · 2021–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMidlab Incorporated history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Midlab Incorporated?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected Midlab Incorporated?
Clinton J. Lott is named on this Form 483, for the inspection of Aug 1 – Aug 5, 2022. Each investigator has a profile showing what they cite most.
When was Midlab Incorporated inspected by FDA?
The inspection ran Aug 1 – Aug 5, 2022, and the Form 483 is dated August 5, 2022.
How do I get the full Form 483 for Midlab Incorporated?
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.