FDA Inspection
Tec Laboratories, Inc.Tec Laboratories, Inc. – FDA Inspection, Aug 9, 2019
Record Details
This FDA Inspection record concerns Tec Laboratories, Inc., with an inspection on August 9, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · a1094144-0307-4f43-a548-b6ad413a5904
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1099983
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 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 |
| 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 |
| October 28, 2011 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Tec Laboratories, Inc.
- FDA Inspection 1172658 - 2022-05-19
- FDA Inspection 1058784 - 2018-07-13
- FDA Inspection 941729 - 2015-08-20
- FDA Inspection 819220 - 2013-02-07
- FDA Inspection 753058 - 2011-10-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.