Tetracore, Inc
FDA inspection history in Rockville, Maryland, 2009 to 2019
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2009: one warning letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter, at Rockville, Maryland.
- 2019One Form 483, at Rockville, Maryland.
Cited most
Across all Tetracore observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.30(g)Design controls1
- 21 CFR 820.70Production and process controls1
The complete Tetracore 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
Rockville, Maryland
One Form 483 and one warning letter · 2009 to 2019 · 5 observations
Latest: Form 483, Dec 6, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-12-06 | 483 Form 483 | Rockville, Maryland | 5 | $99 |
| 2009-12-01 | Warning letter Warning letter | Rockville, Maryland | — | $99 |
Investigators on these documents
FEI number 3003517954 · most recent document Dec 6, 2019
About Tetracore, Inc
How many FDA Form 483s has Tetracore, Inc received?
FDA Intel has 1 Form 483 on file for Tetracore, Inc; the most recent is dated Dec 6, 2019.
When was Tetracore, Inc last inspected by FDA?
The most recent FDA inspection document on file for Tetracore, Inc is a Form 483 dated Dec 6, 2019, for the site in Rockville, Maryland.
What did FDA cite at Tetracore, Inc?
The regulations cited most in the observations on file for Tetracore, Inc are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.20(c) (Management responsibility), 1 time; 21 CFR 820.22 (Quality audit), 1 time.
Has Tetracore, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Tetracore, Inc; the most recent is dated Dec 1, 2009.