FDA Inspection
Tec Laboratories, Inc.Tec Laboratories, Inc. – FDA Inspection, Jul 13, 2018
Record Details
This FDA Inspection record concerns Tec Laboratories, Inc., with an inspection on July 13, 2018, issued by the Seattle District Office, covering human drugs.
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ID · f2638cd0-1bc7-4170-9b49-6aa3f6c2d34b
Inspection Facts
- Inspection number
- 1058784
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
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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 |
| 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 1099983 - 2019-08-09
- FDA Inspection 941729 - 2015-08-20
- FDA Inspection 819220 - 2013-02-07
- FDA Inspection 753058 - 2011-10-28
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