Kalchem International, Inc
Form 483 issued November 3, 2017 · Lindsay, Oklahoma
- Inspection
- Nov 3, 2017
- Investigator
- Margaret M. Annes
- Observations
- 9
- Pages
- 6
- FEI number
- 1000160137
In short: On November 3, 2017, FDA issued a Form 483 with 9 observations to Kalchem International, Inc in Lindsay, Oklahoma (FEI 1000160137) after an inspection that ran Nov 3, 2017. The investigator was Margaret M. Annes. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.186 (master production and control records).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.186 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are lacking which describe in sufficient detail the receipt, approval, and rejection of components…
- 02
There is a lack of written procedures describing in sufficient detail the receipt, identification, sampling, and…
- 03
The number of containers to be sampled and amount of material taken from each container is…
- 04
Batch production and control records do not include complete labeling control records, including specimens or copies…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmKalchem International, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.186
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kalchem International, Inc?
FDA listed 9 observations on this Form 483, mostly about production, materials and packaging & labeling. The most-cited regulation is 21 CFR 211.186 (master production and control records). The opening words of each observation are shown on this page.
Who inspected Kalchem International, Inc?
Margaret M. Annes is named on this Form 483, for the inspection of Nov 3, 2017. Each investigator has a profile showing what they cite most.
When was Kalchem International, Inc inspected by FDA?
The inspection ran Nov 3, 2017, and the Form 483 is dated November 3, 2017.
How do I get the full Form 483 for Kalchem International, 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.