KV Pharmaceutical
Form 483 issued February 2, 2009 · Saint Louis, Missouri
- Inspection
- Dec 15, 2008 – Feb 2, 2009
- Investigators
- Eric C. Nielsen· Gwyn G. Dickinson· Jennifer Cahill
- Observations
- 32
- Pages
- 37
- FEI number
- 3007259359
In short: On February 2, 2009, FDA issued a Form 483 with 32 observations to KV Pharmaceutical in Saint Louis, Missouri (FEI 3007259359) after an inspection that ran Dec 15, 2008 – Feb 2, 2009. The investigators were Eric C. Nielsen, Gwyn G. Dickinson, Jennifer Cahill, Joseph R. Lambert, Kara L. Roden, Matthew J. Morrison, Michele Perry Williams, Patrick L. Wisor, Regina Brown, Tara L. King and Warren J. Lopicka. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (5×) · 211.194 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 04
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
This inspection in context
Eric C. Nielsen
1 document · 2009
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
The firmKV Pharmaceutical history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KV Pharmaceutical?
FDA listed 32 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected KV Pharmaceutical?
Eric C. Nielsen, Gwyn G. Dickinson, Jennifer Cahill, Joseph R. Lambert, Kara L. Roden, Matthew J. Morrison, Michele Perry Williams, Patrick L. Wisor, Regina Brown, Tara L. King and Warren J. Lopicka are named on this Form 483, for the inspection of Dec 15, 2008 – Feb 2, 2009. Each investigator has a profile showing what they cite most.
When was KV Pharmaceutical inspected by FDA?
The inspection ran Dec 15, 2008 – Feb 2, 2009, and the Form 483 is dated February 2, 2009.
How do I get the full Form 483 for KV Pharmaceutical?
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.