Piedmont Hospital, Inc. dba Phcy-Corp.
Form 483 issued February 18, 2020 · Atlanta, Georgia
- Inspection
- Jan 30 – Feb 18, 2020
- Investigators
- Kcmejwnab Opara· Veronica Fuentes
- Observations
- 1
- Pages
- 1
- FEI number
- 1075523
In short: On February 18, 2020, FDA issued a Form 483 with 1 observation to Piedmont Hospital, Inc. dba Phcy-Corp. in Atlanta, Georgia (FEI 1075523) after an inspection that ran Jan 30 – Feb 18, 2020. The investigators were Kcmejwnab Opara and Veronica Fuentes. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
This inspection in context
Kcmejwnab Opara
1 document · 2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Georgia.
The firmPiedmont Hospital, Inc. dba Phcy-Corp. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Piedmont Hospital, Inc. dba Phcy-Corp.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Piedmont Hospital, Inc. dba Phcy-Corp.?
Kcmejwnab Opara and Veronica Fuentes are named on this Form 483, for the inspection of Jan 30 – Feb 18, 2020. Each investigator has a profile showing what they cite most.
When was Piedmont Hospital, Inc. dba Phcy-Corp. inspected by FDA?
The inspection ran Jan 30 – Feb 18, 2020, and the Form 483 is dated February 18, 2020.
How do I get the full Form 483 for Piedmont Hospital, Inc. dba Phcy-Corp.?
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.