Klocke of America, Inc
Form 483 issued March 30, 2022 · Fort Myers, Florida
- Inspection
- Mar 28 – Mar 30, 2022
- Investigators
- Damaris Y. Hernandez· Dorothy P. Kramer· Nicole E. Knowlton
- Observations
- 4
- Pages
- 4
- FEI number
- 3002371949
In short: On March 30, 2022, FDA issued a Form 483 with 4 observations to Klocke of America, Inc in Fort Myers, Florida (FEI 3002371949) after an inspection that ran Mar 28 – Mar 30, 2022. The investigators were Damaris Y. Hernandez, Dorothy P. Kramer and Nicole E. Knowlton. Most observations concern facilities & equipment and quality system.
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 03
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmKlocke of America, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Klocke of America, Inc?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Klocke of America, Inc?
Damaris Y. Hernandez, Dorothy P. Kramer and Nicole E. Knowlton are named on this Form 483, for the inspection of Mar 28 – Mar 30, 2022. Each investigator has a profile showing what they cite most.
When was Klocke of America, Inc inspected by FDA?
The inspection ran Mar 28 – Mar 30, 2022, and the Form 483 is dated March 30, 2022.
How do I get the full Form 483 for Klocke of America, 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.