Meditech Laboratories, Inc.
FDA inspection history in Las Vegas, Nevada, 2016 to 2017
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2016: one warning letter and one Form 483; 2017: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17Two Form 483s, one warning letter and one close-out letter, at Las Vegas, Nevada.
- 2016The longest 483 on file: 13 observations over 9 pages at Las Vegas, Nevada.
Cited most
Across all Meditech Laboratories observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features3
- 21 CFR 211.192Production record review2
- 21 CFR 211.94(b)Drug product containers and closures2
- 21 CFR 211.137(a)Expiration dating1
- 21 CFR 211.150Distribution procedures1
The complete Meditech Laboratories file.
All 4 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
Las Vegas, Nevada
Two Form 483s, one close-out letter and one warning letter · 2016 to 2017 · 14 observations
Latest: Close-out, Dec 6, 2017 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-12-06 | Close-out Close-out letter | Las Vegas, Nevada | — | $99 |
| 2017-05-11 | 483 Form 483 | Las Vegas, Nevada | 1 | $99 |
| 2016-10-19 | Warning letter Warning letter | Las Vegas, Nevada | — | $99 |
| 2016-03-18 | 483 Form 483 | Las Vegas, Nevada | 13 | $99 |
Investigators on these documents
David Eng (1)Dustin P. Tran (1)Eileen A. Liu (1)Rumany C. Penn (1)
FEI number 3012200488 · most recent document Dec 6, 2017
About Meditech Laboratories, Inc.
How many FDA Form 483s has Meditech Laboratories, Inc. received?
FDA Intel has 2 Form 483s on file for Meditech Laboratories, Inc.; the most recent is dated May 11, 2017.
When was Meditech Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Meditech Laboratories, Inc. is a Form 483 dated May 11, 2017, for the site in Las Vegas, Nevada.
What did FDA cite at Meditech Laboratories, Inc.?
The regulations cited most in the observations on file for Meditech Laboratories, Inc. are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.94(b) (Drug product containers and closures), 2 times.
Has Meditech Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Meditech Laboratories, Inc.; the most recent is dated Oct 19, 2016.