Tower Laboratories Ltd
Form 483 issued May 2, 2019 · Montague, Michigan
- Inspection
- Apr 23 – May 2, 2019
- Investigator
- Theodore N. Sietsema
- Observations
- 1
- Pages
- 3
- FEI number
- 1823985
In short: On May 2, 2019, FDA issued a Form 483 with 1 observation to Tower Laboratories Ltd in Montague, Michigan (FEI 1823985) after an inspection that ran Apr 23 – May 2, 2019. The investigator was Theodore N. Sietsema. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.320 (what requirements apply to laboratory methods for testing and examination?).
At a glance
1 of 1 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.320(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
You did not verify that the laboratory examination and testing methodologies are appropriate…
This inspection in context
Theodore N. Sietsema
2 documents · 2019
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
The firmTower Laboratories Ltd history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 111.320(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tower Laboratories Ltd?
FDA listed 1 observation on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.320 (what requirements apply to laboratory methods for testing and examination?). The opening words of each observation are shown on this page.
Who inspected Tower Laboratories Ltd?
Theodore N. Sietsema is named on this Form 483, for the inspection of Apr 23 – May 2, 2019. Each investigator has a profile showing what they cite most.
When was Tower Laboratories Ltd inspected by FDA?
The inspection ran Apr 23 – May 2, 2019, and the Form 483 is dated May 2, 2019.
How do I get the full Form 483 for Tower Laboratories Ltd?
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.