Midlab Incorporated
FDA inspection history in Athens, Tennessee, 2022 to 2023
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23One Form 483 and one warning letter, at Athens, Tennessee.
Cited most
Across all Midlab Incorporated observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.115(a)Reprocessing1
- 21 CFR 211.165(b)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete Midlab Incorporated file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Athens, Tennessee
One warning letter and one Form 483 · 2022 to 2023 · 6 observations
Latest: Warning letter, Feb 15, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-02-15 | Warning letter Warning letter | Athens, Tennessee | — | $99 |
| 2022-08-05 | 483 Form 483 | Athens, Tennessee | 6 | $99 |
Investigators on these documents
FEI number 3001236208 · most recent document Feb 15, 2023
About Midlab Incorporated
How many FDA Form 483s has Midlab Incorporated received?
FDA Intel has 1 Form 483 on file for Midlab Incorporated; the most recent is dated Aug 5, 2022.
When was Midlab Incorporated last inspected by FDA?
The most recent FDA inspection document on file for Midlab Incorporated is a Form 483 dated Aug 5, 2022, for the site in Athens, Tennessee.
What did FDA cite at Midlab Incorporated?
The regulations cited most in the observations on file for Midlab Incorporated are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.115(a) (Reprocessing), 1 time; 21 CFR 211.165(b) (Testing and release for distribution), 1 time.
Has Midlab Incorporated received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Midlab Incorporated; the most recent is dated Feb 15, 2023.