Sparhawk Laboratories, Inc.
Form 483 issued March 23, 2021 · Lenexa, Kansas
- Inspection
- Mar 16 – Mar 23, 2021
- Investigators
- Carl A. Huffman· Torrey M. Ward· Wayne D. McGrath
- Observations
- 3
- Pages
- 4
- FEI number
- 1910619
In short: On March 23, 2021, FDA issued a Form 483 with 3 observations to Sparhawk Laboratories, Inc. in Lenexa, Kansas (FEI 1910619) after an inspection that ran Mar 16 – Mar 23, 2021. The investigators were Carl A. Huffman, Torrey M. Ward and Wayne D. McGrath. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (2×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Carl A. Huffman
11 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sparhawk Laboratories, Inc.?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sparhawk Laboratories, Inc.?
Carl A. Huffman, Torrey M. Ward and Wayne D. McGrath are named on this Form 483, for the inspection of Mar 16 – Mar 23, 2021. Each investigator has a profile showing what they cite most.
When was Sparhawk Laboratories, Inc. inspected by FDA?
The inspection ran Mar 16 – Mar 23, 2021, and the Form 483 is dated March 23, 2021.
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.