FDA Inspection
Tec Laboratories, Inc.Tec Laboratories, Inc. – FDA Inspection, Oct 30, 2009
Record Details
This FDA Inspection record concerns Tec Laboratories, Inc., with an inspection on October 30, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Tec Laboratories, Inc.
- Inspection Date
- October 30, 2009
- Product Type
- Drugs
View Company Profile
ID · 425de98d-1191-468d-b1fd-69610476686e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 626811
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
5- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.52Washing and toilet facilities are deficient
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tec Laboratories, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 9, 2019 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| July 13, 2018 | Not classified | Seattle District Office | Drug Quality Assurance |
| August 20, 2015 | NAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| February 7, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Tec Laboratories, Inc.
- FDA Inspection 1172658 - 2022-05-19
- FDA Inspection 1099983 - 2019-08-09
- FDA Inspection 1058784 - 2018-07-13
- FDA Inspection 941729 - 2015-08-20
- FDA Inspection 819220 - 2013-02-07
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