Chemco Corp
Form 483 issued March 6, 2017 · Miami Lakes, Florida
- Inspection
- Feb 21 – Mar 6, 2017
- Investigators
- Jennifer Lalama· Rozelle G. Smith
- Observations
- 6
- Pages
- 6
- FEI number
- 1042599
In short: On March 6, 2017, FDA issued a Form 483 with 6 observations to Chemco Corp in Miami Lakes, Florida (FEI 1042599) after an inspection that ran Feb 21 – Mar 6, 2017. The investigators were Jennifer Lalama and Rozelle G. Smith. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Distributor There is a failure to thoroughly review the failure of a batch or any of…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) 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 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chemco Corp?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Chemco Corp?
Jennifer Lalama and Rozelle G. Smith are named on this Form 483, for the inspection of Feb 21 – Mar 6, 2017. Each investigator has a profile showing what they cite most.
When was Chemco Corp inspected by FDA?
The inspection ran Feb 21 – Mar 6, 2017, and the Form 483 is dated March 6, 2017.
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.