Tec Laboratories, Inc.
Form 483 issued August 9, 2019 · Albany, Oregon
- Inspection
- Aug 6 – Aug 9, 2019
- Investigator
- Liming Zhang
- Observations
- 7
- Pages
- 5
- FEI number
- 3021059
In short: On August 9, 2019, FDA issued a Form 483 with 7 observations to Tec Laboratories, Inc. in Albany, Oregon (FEI 3021059) after an inspection that ran Aug 6 – Aug 9, 2019. The investigator was Liming Zhang. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Facilities & equipment and production account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written production and process control procedures are not followed in the execution of production and process…
- 03
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and…
- 04
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
This inspection in context
Liming Zhang
19 documents · 2014–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmTec Laboratories, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tec Laboratories, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Tec Laboratories, Inc.?
Liming Zhang is named on this Form 483, for the inspection of Aug 6 – Aug 9, 2019. Each investigator has a profile showing what they cite most.
When was Tec Laboratories, Inc. inspected by FDA?
The inspection ran Aug 6 – Aug 9, 2019, and the Form 483 is dated August 9, 2019.
How do I get the full Form 483 for Tec Laboratories, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.