Hybrid Pharma LLC

Form 483 issued November 9, 2023 · Deerfield Beach, Florida

Inspection: Oct 16 – Nov 9, 2023
Investigator: Joanne E. King
Observations: 11
Pages: 11
FEI number: 3011319445

In short: On November 9, 2023, FDA issued a Form 483 with 11 observations to Hybrid Pharma LLC in Deerfield Beach, Florida (FEI 3011319445) after an inspection that ran Oct 16 – Nov 9, 2023. The investigator was Joanne E. King. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and laboratory controls account for 7 of 11 observations.

Facilities & equipment4

Laboratory controls3

Production2

Other2

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
02
21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
03
21 CFR 211.42(c)(10)(iii)
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
04
21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…

7 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Joanne E. King

34 documents · 2013–2026

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.

The firm

Hybrid Pharma LLC history

All 7 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.42(c)(10)(v)

See how FDA wrote the same problem up elsewhere.

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Response
The firm's reply to this 483Jan 31, 2024$199

Hybrid Pharma LLC site file

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Questions about this 483

What did FDA find at Hybrid Pharma LLC?

FDA listed 11 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected Hybrid Pharma LLC?

Joanne E. King is named on this Form 483, for the inspection of Oct 16 – Nov 9, 2023. Each investigator has a profile showing what they cite most.

When was Hybrid Pharma LLC inspected by FDA?

The inspection ran Oct 16 – Nov 9, 2023, and the Form 483 is dated November 9, 2023.

How do I get the full Form 483 for Hybrid Pharma LLC?

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.