Sparhawk Laboratories, Inc.
Form 483 issued February 28, 2020 · Lenexa, Kansas
- Inspection
- Feb 18 – Feb 28, 2020
- Investigators
- Ana P. Sandee· Carl A. Huffman· James K. Rice
- Observations
- 6
- Pages
- 10
- FEI number
- 1910619
In short: On February 28, 2020, FDA issued a Form 483 with 6 observations to Sparhawk Laboratories, Inc. in Lenexa, Kansas (FEI 1910619) after an inspection that ran Feb 18 – Feb 28, 2020. The investigators were Ana P. Sandee, Carl A. Huffman, James K. Rice and Laura S. Huffman. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the handling of all written and oral complaints regarding a drug…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Results of stability testing are not used in…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Ana P. Sandee
6 documents · 2019–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Missouri.
The firmSparhawk Laboratories, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sparhawk Laboratories, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sparhawk Laboratories, Inc.?
Ana P. Sandee, Carl A. Huffman, James K. Rice and Laura S. Huffman are named on this Form 483, for the inspection of Feb 18 – Feb 28, 2020. Each investigator has a profile showing what they cite most.
When was Sparhawk Laboratories, Inc. inspected by FDA?
The inspection ran Feb 18 – Feb 28, 2020, and the Form 483 is dated February 28, 2020.
How do I get the full Form 483 for Sparhawk Laboratories, Inc.?
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.