Pavilion Compounding Pharmacy
Form 483 issued February 8, 2019 · Atlanta, Georgia
- Inspection
- Feb 4 – Feb 8, 2019
- Investigator
- Jennifer L. Huntington
- Observations
- 5
- Pages
- 4
- FEI number
- 3004570352
In short: On February 8, 2019, FDA issued a Form 483 with 5 observations to Pavilion Compounding Pharmacy in Atlanta, Georgia (FEI 3004570352) after an inspection that ran Feb 4 – Feb 8, 2019. The investigator was Jennifer L. Huntington. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 3 of 5 observations.
Most cited: FDCA 501(a)(2)(A) (2×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You produced hazardous chugs without providing adequate containment, segregation and cleaning of…
- 02FDCA 501(a)(2)(A)
Unsealed, loose ceiling tiles were…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmPavilion Compounding Pharmacy history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pavilion Compounding Pharmacy?
FDA listed 5 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Pavilion Compounding Pharmacy?
Jennifer L. Huntington is named on this Form 483, for the inspection of Feb 4 – Feb 8, 2019. Each investigator has a profile showing what they cite most.
When was Pavilion Compounding Pharmacy inspected by FDA?
The inspection ran Feb 4 – Feb 8, 2019, and the Form 483 is dated February 8, 2019.
How do I get the full Form 483 for Pavilion Compounding Pharmacy?
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.