ALCHEM LABORATORIES CORPORATION
Form 483 issued February 16, 2005 · ALACHUA, Florida
- Observations
- 3
- Pages
- 3
- FEI number
- 3002303056
In short: On February 16, 2005, FDA issued a Form 483 with 3 observations to ALCHEM LABORATORIES CORPORATION in ALACHUA, Florida (FEI 3002303056). Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Materials and laboratory controls account for 2 of 3 observations.
Most cited: 21 CFR 211.80 (1×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to follow SOP 2-002 "Handling and storage for raw materials to be used in GMP…
- 02
Failure to follow SOP 4-004 "Policy on Laboratory Notebooks, Worksheets and Adjunctive Data” , issued by…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at ALCHEM LABORATORIES CORPORATION?
FDA listed 3 observations on this Form 483, mostly about materials and laboratory controls. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
When was ALCHEM LABORATORIES CORPORATION inspected by FDA?
This Form 483 is dated February 16, 2005.
How do I get the full Form 483 for ALCHEM LABORATORIES CORPORATION?
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.