Frontida BioPharm, LLC
Form 483 issued December 7, 2023 · Philadelphia, Pennsylvania
- Inspection
- Nov 28 – Dec 7, 2023
- Investigator
- Anastasia M. Shields
- Observations
- 2
- Pages
- 4
- FEI number
- 2523348
In short: On December 7, 2023, FDA issued a Form 483 with 2 observations to Frontida BioPharm, LLC in Philadelphia, Pennsylvania (FEI 2523348) after an inspection that ran Nov 28 – Dec 7, 2023. The investigator was Anastasia M. Shields. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 314.81 (other postmarketing reports).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 314.81 (1×) · 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
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 02
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmFrontida BioPharm, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.81
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Frontida BioPharm, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 314.81 (other postmarketing reports). The opening words of each observation are shown on this page.
Who inspected Frontida BioPharm, LLC?
Anastasia M. Shields is named on this Form 483, for the inspection of Nov 28 – Dec 7, 2023. Each investigator has a profile showing what they cite most.
When was Frontida BioPharm, LLC inspected by FDA?
The inspection ran Nov 28 – Dec 7, 2023, and the Form 483 is dated December 7, 2023.
How do I get the full Form 483 for Frontida BioPharm, 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.