Pharmcore Inc. dba Hallandale Pharmacy
Form 483 issued September 24, 2021 · Fort Lauderdal e, Florida
- Inspection
- Sep 13 – Sep 24, 2021
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 3
- Pages
- 3
- FEI number
- 3014480778
In short: On September 24, 2021, FDA issued a Form 483 with 3 observations to Pharmcore Inc. dba Hallandale Pharmacy in Fort Lauderdal e, Florida (FEI 3014480778) after an inspection that ran Sep 13 – Sep 24, 2021. The investigator was Patty P. Kaewussdangkul. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Cleaning procedures are inadequate…
- 02
You did not take remedial action where actionable microbial contamination was found to be present in…
- 03
Materials or supplies were not disinfected prior to entering…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmPharmcore Inc. dba Hallandale Pharmacy history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
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 Pharmcore Inc. dba Hallandale Pharmacy?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. 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 Pharmcore Inc. dba Hallandale Pharmacy?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Sep 13 – Sep 24, 2021. Each investigator has a profile showing what they cite most.
When was Pharmcore Inc. dba Hallandale Pharmacy inspected by FDA?
The inspection ran Sep 13 – Sep 24, 2021, and the Form 483 is dated September 24, 2021.
How do I get the full Form 483 for Pharmcore Inc. dba Hallandale Pharmacy?
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