Basic Drugs Inc
Form 483 issued December 8, 2016 · Vandalia, Ohio
- Inspection
- Dec 7 – Dec 8, 2016
- Investigators
- Kenneth E. Felkley· Lindsey M. Schwierjohann
- Observations
- 2
- Pages
- 2
- FEI number
- 1521546
In short: On December 8, 2016, FDA issued a Form 483 with 2 observations to Basic Drugs Inc in Vandalia, Ohio (FEI 1521546) after an inspection that ran Dec 7 – Dec 8, 2016. The investigators were Kenneth E. Felkley and Lindsey M. Schwierjohann. Most observations concern packaging & labeling and production; the most-cited regulation is 21 CFR 211.125 (labeling issuance).
At a glance
Packaging & labeling and production account for 2 of 2 observations.
Most cited: 21 CFR 211.125(a) (1×) · 211.103 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Strict control is not exercised over labeling issued for use in…
- 02
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Kenneth E. Felkley
3 documents · 2016–2018
Cites 117.20 (plant and grounds) more than any other section. Most of their documents are for sites in Germany.
The firmBasic Drugs Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.125(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Basic Drugs Inc?
FDA listed 2 observations on this Form 483, mostly about packaging & labeling and production. The most-cited regulation is 21 CFR 211.125 (labeling issuance). The opening words of each observation are shown on this page.
Who inspected Basic Drugs Inc?
Kenneth E. Felkley and Lindsey M. Schwierjohann are named on this Form 483, for the inspection of Dec 7 – Dec 8, 2016. Each investigator has a profile showing what they cite most.
When was Basic Drugs Inc inspected by FDA?
The inspection ran Dec 7 – Dec 8, 2016, and the Form 483 is dated December 8, 2016.
How do I get the full Form 483 for Basic Drugs 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.