Partners In Care, Inc.
Form 483 issued June 10, 2016 · Gainesville, Georgia
- Inspection
- May 24, 2016 – Jun 9, 2020
- Investigators
- Rachael L. Cook· Tamara J. Henderson
- Observations
- 6
- Pages
- 5
- FEI number
- 3005471681
In short: On June 10, 2016, FDA issued a Form 483 with 6 observations to Partners In Care, Inc. in Gainesville, Georgia (FEI 3005471681) after an inspection that ran May 24, 2016 – Jun 9, 2020. The investigators were Rachael L. Cook and Tamara J. Henderson. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Materials and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.80 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no written testing progrdill designed to assess lhc stability…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Then.: wa-; a failure to handle and store closures at all times in a…
- 04
Written procedures arc lacking which <.k:scribc in :;uillcicnt detail th<.: approval and rejection of components. Your…
This inspection in context
Rachael L. Cook
8 documents · 2016–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Georgia.
The firmPartners In Care, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Partners In Care, Inc.?
FDA listed 6 observations on this Form 483, mostly about materials, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Partners In Care, Inc.?
Rachael L. Cook and Tamara J. Henderson are named on this Form 483, for the inspection of May 24, 2016 – Jun 9, 2020. Each investigator has a profile showing what they cite most.
When was Partners In Care, Inc. inspected by FDA?
The inspection ran May 24, 2016 – Jun 9, 2020, and the Form 483 is dated June 10, 2016.
How do I get the full Form 483 for Partners In Care, 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.