Tower Laboratories Ltd
Form 483 issued November 17, 2021 · Montague, Michigan
- Inspection
- Nov 2 – Nov 17, 2021
- Investigator
- Constantin Y. Philopoulos
- Observations
- 4
- Pages
- 6
- FEI number
- 1823985
In short: On November 17, 2021, FDA issued a Form 483 with 4 observations to Tower Laboratories Ltd in Montague, Michigan (FEI 1823985) after an inspection that ran Nov 2 – Nov 17, 2021. The investigator was Constantin Y. Philopoulos. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production and. process…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
Your examination and testing of samples did not assure that the drug product and in-process…
This inspection in context
Constantin Y. Philopoulos
9 documents · 2010–2021
Cites 211.42 (design and construction features) 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 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tower Laboratories Ltd?
FDA listed 4 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Tower Laboratories Ltd?
Constantin Y. Philopoulos is named on this Form 483, for the inspection of Nov 2 – Nov 17, 2021. Each investigator has a profile showing what they cite most.
When was Tower Laboratories Ltd inspected by FDA?
The inspection ran Nov 2 – Nov 17, 2021, and the Form 483 is dated November 17, 2021.
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.