Tec Laboratories, Inc.
FDA inspection history in Albany, Oregon, 2011 to 2019
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2011: one warning letter; 2019: one Form 483 and one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter, at Albany, Oregon.
- 2019One Form 483 and one close-out letter, at Albany, Oregon.
Cited most
Across all Tec Laboratories observations on file
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.42(c)(5)Design and construction features1
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment1
The complete Tec Laboratories file.
All 3 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
Albany, Oregon
One Form 483, one close-out letter and one warning letter · 2011 to 2019 · 7 observations
Latest: Form 483, Aug 9, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-09 | 483 Form 483 | Albany, Oregon | 7 | $99 |
| 2019-03-20 | Close-out Close-out letter | Albany, Oregon | — | $99 |
| 2011-04-18 | Warning letter Warning letter | Albany, Oregon | — | $99 |
Investigators on these documents
FEI number 3021059 · most recent document Aug 9, 2019
About Tec Laboratories, Inc.
How many FDA Form 483s has Tec Laboratories, Inc. received?
FDA Intel has 1 Form 483 on file for Tec Laboratories, Inc.; the most recent is dated Aug 9, 2019.
When was Tec Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Tec Laboratories, Inc. is a Form 483 dated Aug 9, 2019, for the site in Albany, Oregon.
What did FDA cite at Tec Laboratories, Inc.?
The regulations cited most in the observations on file for Tec Laboratories, Inc. are 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.
Has Tec Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Tec Laboratories, Inc.; the most recent is dated Apr 18, 2011.