Hybrid Pharma LLC
Amended 483 issued June 20, 2019 · Deerfield Beach, Florida
- Inspection
- May 20 – Jun 20, 2019
- Investigator
- Bonita S. Chester
- Observations
- 11
- Pages
- 8
- FEI number
- 3011319445
In short: On June 20, 2019, FDA issued a Amended 483 with 11 observations to Hybrid Pharma LLC in Deerfield Beach, Florida (FEI 3011319445) after an inspection that ran May 20 – Jun 20, 2019. The investigator was Bonita S. Chester. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient in that floors and ceilings are not smooth and/or hard surfaces…
7 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Bonita S. Chester
17 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmHybrid Pharma LLC history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Hybrid Pharma LLC?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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?
Bonita S. Chester is named on this Amended 483, for the inspection of May 20 – Jun 20, 2019. Each investigator has a profile showing what they cite most.
When was Hybrid Pharma LLC inspected by FDA?
The inspection ran May 20 – Jun 20, 2019, and the Amended 483 is dated June 20, 2019.
How do I get the full Amended 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.