FDA Inspection
Tec Laboratories, Inc.Tec Laboratories, Inc. – FDA Inspection, Oct 28, 2011
Record Details
This FDA Inspection record concerns Tec Laboratories, Inc., with an inspection on October 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Tec Laboratories, Inc.
- Inspection Date
- October 28, 2011
- Product Type
- Drugs
View Company Profile
ID · df5b4c76-c868-4f05-8dd9-52b59020b20b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 753058
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
4- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 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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