Meditech Laboratories, Inc.
Form 483 issued March 18, 2016 · Las Vegas, Nevada
- Inspection
- Mar 10 – Mar 18, 2016
- Investigators
- David Eng· Dustin P. Tran· Eileen A. Liu
- Observations
- 13
- Pages
- 9
- FEI number
- 3012200488
In short: On March 18, 2016, FDA issued a Form 483 with 13 observations to Meditech Laboratories, Inc. in Las Vegas, Nevada (FEI 3012200488) after an inspection that ran Mar 10 – Mar 18, 2016. The investigators were David Eng, Dustin P. Tran and Eileen A. Liu. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Drug product production and control records, are not approved by the quality control unit to determine…
- 04
Protective apparel is not worn as necessary to protect…
This inspection in context
David Eng
5 documents · 2015–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmMeditech Laboratories, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Meditech Laboratories, Inc.?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Meditech Laboratories, Inc.?
David Eng, Dustin P. Tran and Eileen A. Liu are named on this Form 483, for the inspection of Mar 10 – Mar 18, 2016. Each investigator has a profile showing what they cite most.
When was Meditech Laboratories, Inc. inspected by FDA?
The inspection ran Mar 10 – Mar 18, 2016, and the Form 483 is dated March 18, 2016.
How do I get the full Form 483 for Meditech 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.