Frontida BioPharm, LLC
Form 483 issued July 17, 2015 · Philadelphia, Pennsylvania
- Inspection
- Jun 15 – Jul 17, 2015
- Investigators
- Gayle S. Lawson· Lisa B. Orr· Sharon K. Thoma
- Observations
- 10
- Pages
- 9
- FEI number
- 2523348
In short: On July 17, 2015, FDA issued a Form 483 with 10 observations to Frontida BioPharm, LLC in Philadelphia, Pennsylvania (FEI 2523348) after an inspection that ran Jun 15 – Jul 17, 2015. The investigators were Gayle S. Lawson, Lisa B. Orr and Sharon K. Thoma. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 314.81 (other postmarketing reports).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established standards, specifications, and quality control…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Gayle S. Lawson
10 documents · 2015–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.165(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Frontida BioPharm, LLC?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, quality system and production. 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?
Gayle S. Lawson, Lisa B. Orr and Sharon K. Thoma are named on this Form 483, for the inspection of Jun 15 – Jul 17, 2015. Each investigator has a profile showing what they cite most.
When was Frontida BioPharm, LLC inspected by FDA?
The inspection ran Jun 15 – Jul 17, 2015, and the Form 483 is dated July 17, 2015.
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.