Meditech Laboratories, Inc.
Form 483 issued May 11, 2017 · Las Vegas, Nevada
- Inspection
- May 9 – May 11, 2017
- Investigator
- Rumany C. Penn
- Observations
- 1
- Pages
- 1
- FEI number
- 3012200488
In short: On May 11, 2017, FDA issued a Form 483 with 1 observation to Meditech Laboratories, Inc. in Las Vegas, Nevada (FEI 3012200488) after an inspection that ran May 9 – May 11, 2017. The investigator was Rumany C. Penn. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drugs were produced without providing adequate containment and cleaning of utensils…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Meditech Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Meditech Laboratories, Inc.?
Rumany C. Penn is named on this Form 483, for the inspection of May 9 – May 11, 2017. Each investigator has a profile showing what they cite most.
When was Meditech Laboratories, Inc. inspected by FDA?
The inspection ran May 9 – May 11, 2017, and the Form 483 is dated May 11, 2017.
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.