Pharmcore Inc. dba Hallandale Pharmacy
Form 483 issued July 2, 2018 · Hallandale Beach, Florida
- Inspection
- Jul 2, 2018
- Investigators
- June P. Page· Melinda Lee
- Observations
- 5
- Pages
- 5
- FEI number
- 3014480778
In short: On July 2, 2018, FDA issued a Form 483 with 5 observations to Pharmcore Inc. dba Hallandale Pharmacy in Hallandale Beach, Florida (FEI 3014480778) after an inspection that ran Jul 2, 2018. The investigators were June P. Page and Melinda Lee. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (4×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO-classified areas have difficult to clean, particle-generating, or visibly…
- 02
Your firm continued producing sterile drug products within your facility without establishing adequate controls to prevent…
- 03
The system for monitoring and maintaining environmental conditions in the aseptic…
- 04
Equipment, materials, and/or supplies are not disinfected prior to entering…
This inspection in context
June P. Page
30 documents · 2015–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
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 5 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?
June P. Page and Melinda Lee are named on this Form 483, for the inspection of Jul 2, 2018. Each investigator has a profile showing what they cite most.
When was Pharmcore Inc. dba Hallandale Pharmacy inspected by FDA?
The inspection ran Jul 2, 2018, and the Form 483 is dated July 2, 2018.
How do I get the full Form 483 for Pharmcore Inc. dba Hallandale 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.