Chemco Corp
Form 483 issued October 31, 2022 · Hialeah, Florida
- Inspection
- Oct 17 – Oct 31, 2022
- Investigators
- Damaris Y. Hernandez· Jennifer Lalama
- Observations
- 5
- Pages
- 7
- FEI number
- 1042599
In short: On October 31, 2022, FDA issued a Form 483 with 5 observations to Chemco Corp in Hialeah, Florida (FEI 1042599) after an inspection that ran Oct 17 – Oct 31, 2022. The investigators were Damaris Y. Hernandez and Jennifer Lalama. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Laboratory controls and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Established standards and laboratory control mechanisms are not followed and documented at…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
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 firmChemco Corp history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chemco Corp?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Chemco Corp?
Damaris Y. Hernandez and Jennifer Lalama are named on this Form 483, for the inspection of Oct 17 – Oct 31, 2022. Each investigator has a profile showing what they cite most.
When was Chemco Corp inspected by FDA?
The inspection ran Oct 17 – Oct 31, 2022, and the Form 483 is dated October 31, 2022.
How do I get the full Form 483 for Chemco Corp?
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.