PMC Biogenix, Inc.
Form 483 issued April 27, 2017 · Memphis, Tennessee
- Inspection
- Apr 25 – Apr 27, 2017
- Investigator
- Claire M. Minden
- Observations
- 3
- Pages
- 3
- FEI number
- 1030293
In short: On April 27, 2017, FDA issued a Form 483 with 3 observations to PMC Biogenix, Inc. in Memphis, Tennessee (FEI 1030293) after an inspection that ran Apr 25 – Apr 27, 2017. The investigator was Claire M. Minden. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 2 of 3 observations.
Most cited: 21 CFR 211.67 (1×) · 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils should be cleaned, stored, and sanitized to prevent contamination or carry-over of a…
- 02
Regular quality-reviews of APIs should be conducted with the objective of verifying the…
- 03
Qualification is usually carried out by conducting the following activities: + Performance Qualification is the documented…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmPMC Biogenix, Inc. history
The site's inspection history, in date order.
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 PMC Biogenix, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. 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 PMC Biogenix, Inc.?
Claire M. Minden is named on this Form 483, for the inspection of Apr 25 – Apr 27, 2017. Each investigator has a profile showing what they cite most.
When was PMC Biogenix, Inc. inspected by FDA?
The inspection ran Apr 25 – Apr 27, 2017, and the Form 483 is dated April 27, 2017.
How do I get the full Form 483 for PMC Biogenix, 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.