Spirit Pharmaceuticals
Form 483 issued January 25, 2017 · Ronkonkoma, New York
- Inspection
- Jan 18 – Jan 25, 2017
- Investigator
- Robert C. Horan
- Observations
- 2
- Pages
- 3
- FEI number
- 3011773798
In short: On January 25, 2017, FDA issued a Form 483 with 2 observations to Spirit Pharmaceuticals in Ronkonkoma, New York (FEI 3011773798) after an inspection that ran Jan 18 – Jan 25, 2017. The investigator was Robert C. Horan. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.68(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Routine checking of electronic equipment is not performed according to a written program designed…
This inspection in context
Robert C. Horan
13 documents · 1998–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New York.
The firmSpirit Pharmaceuticals history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spirit Pharmaceuticals?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Spirit Pharmaceuticals?
Robert C. Horan is named on this Form 483, for the inspection of Jan 18 – Jan 25, 2017. Each investigator has a profile showing what they cite most.
When was Spirit Pharmaceuticals inspected by FDA?
The inspection ran Jan 18 – Jan 25, 2017, and the Form 483 is dated January 25, 2017.
How do I get the full Form 483 for Spirit Pharmaceuticals?
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.